Chrysalis Intelligence · Sponsors · MicroVention, Inc.

MicroVention, Inc.

Aliso Viejo, CA, US · 13 510(k) clearances · 45 PMAs · 14 recalls

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Total clearances
13
2020-01-22 → 2025-06-13
Last 12 months
0
Product codes
8
Most recent
2025-06-13
Name variants in FDA filings: Microvention / MicroVention, Inc.
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
DQY — — — 3 2023-01-10
QJP — — — 2 2024-05-16
KRD — — — 2 2022-12-21
MOF — — — 2 2020-07-02
JCX Apparatus, Suction, Ward Use, Portable, Ac-Powered Class II General, Plastic Surgery 1 2025-06-13
NTE — — — 1 2023-04-27
NRY Catheter, Thrombus Retriever Class II Cardiovascular 1 2022-03-31
NOY — — — 1 2020-01-22
Class III

PMA approvals (45)

Total PMA records
45
Originals + supplements
Distinct product codes
4
First decision
2020-01-23
Most recent
2026-07-07
DatePMA #Trade nameTypeCodeDevice nameSpecialty
2026-07-07 P210030-S002 Roadsaver/CASPER Carotid Stent System 30-Day Notice NIM — —
2026-05-28 P170032-S022 Woven EndoBridge (WEB) Aneurysm Embolization System 30-Day Notice OPR Intrasaccular Flow Disruption Device Unknown
2026-05-01 P170032-S021 Woven EndoBridge (WEB) Aneurysm Embolization System 30-Day Notice OPR Intrasaccular Flow Disruption Device Unknown
2026-03-20 P170032-S019 Woven EndoBridge Aneurysm Embolization (WEB) System Normal 180 Day Track No User Fee OPR Intrasaccular Flow Disruption Device Unknown
2025-11-02 P180027-S013 Flow Re-Direction Endoluminal Device (FRED®) System Normal 180 Day Track No User Fee OUT — —
2025-09-20 P180027-S012 Flow Re-Direction Endoluminal Device (FRED) X System Normal 180 Day Track No User Fee OUT — —
2025-09-18 P180027-S014 FRED X System Real-Time Process OUT — —
2025-06-23 P210030-S001 Roadsaver/CASPER Carotid Stent Device Normal 180 Day Track No User Fee NIM — —
2024-11-20 P210030 Roadsaver/CASPER Carotid Stent Device Original NIM — —
2024-09-23 P170032-S017 Woven EndoBridge Aneurysm Embolization (WEB) System Normal 180 Day Track No User Fee OPR Intrasaccular Flow Disruption Device Unknown
2024-08-21 P180027-S011 Flow Re-Direction Endoluminal Device (FRED®) System Normal 180 Day Track No User Fee OUT — —
2024-08-21 P170013-S012 Low-Profile Visualized Intraluminal Support (LVIS), LVIS Jr Normal 180 Day Track No User Fee QCA Intracranial Coil-Assist Stent Unknown
2024-08-14 P170032-S016 Woven EndoBridge (WEB) Aneurysm Embolization System Normal 180 Day Track No User Fee OPR Intrasaccular Flow Disruption Device Unknown
2024-02-05 P170032-S012 Woven EndoBridge (WEB) Aneurysm Embolization System Normal 180 Day Track No User Fee OPR Intrasaccular Flow Disruption Device Unknown
2024-01-17 P180027-S010 FRED 30-Day Notice OUT — —
2024-01-17 P170013-S011 LVIS 30-Day Notice QCA Intracranial Coil-Assist Stent Unknown
2023-11-24 P170032-S014 Woven EndoBridge (WEB) Aneurysm Embolization System Real-Time Process OPR Intrasaccular Flow Disruption Device Unknown
2023-10-04 P170032-S015 Woven EndoBridge (WEB) Aneurysm Embolization System 30-Day Notice OPR Intrasaccular Flow Disruption Device Unknown
2023-05-22 P170032-S013 Woven EndoBridge (WEB) Aneurysm Embolization System 30-Day Notice OPR Intrasaccular Flow Disruption Device Unknown
2022-12-09 P170013-S010 Low-Profile Visualized Intraluminal Support (LVIS) and LVIS Jr. Normal 180 Day Track No User Fee QCA Intracranial Coil-Assist Stent Unknown
2022-07-28 P170013-S004 Low-Profile Visualized Intraluminal Support (LVIS), LVIS Jr., LVIS EVO Normal 180 Day Track QCA Intracranial Coil-Assist Stent Unknown
2022-06-28 P170013-S009 Low-Profile Visualized Intraluminal Support (LVIS) and LVIS Jr. X Normal 180 Day Track No User Fee QCA Intracranial Coil-Assist Stent Unknown
2022-04-26 P180027-S005 FRED X System Normal 180 Day Track No User Fee OUT — —
2022-03-25 P180027-S008 Flow Re-Direction Endoluminal Device (FRED) and FRED X System 30-Day Notice OUT — —
2022-03-01 P180027-S007 Flow Re-Direction Endoluminal Device (FRED®) System, FREDX System 30-Day Notice OUT — —
2022-02-15 P180027-S006 Flow Re-Direction Endoluminal Device (FRED) and FRED X System Real-Time Process OUT — —
2022-01-14 P170032-S011 WEB Aneurysm Embolization System 30-Day Notice OPR Intrasaccular Flow Disruption Device Unknown
2021-12-20 P170032-S010 (WEB) Aneurysm Embolization System 30-Day Notice OPR Intrasaccular Flow Disruption Device Unknown
2021-10-14 P170032-S009 Woven EndoBridge (WEB) Aneurysm Embolization System Real-Time Process OPR Intrasaccular Flow Disruption Device Unknown
2021-10-08 P170013-S007 Low-Profile Visualized Intraluminal Support (LVIS) and LVIS Jr. Normal 180 Day Track No User Fee QCA Intracranial Coil-Assist Stent Unknown
2021-09-16 P180027-S002 Flow Re-Direction Endoluminal Device (FRED®) System Normal 180 Day Track OUT — —
2021-09-16 P170013-S005 Low-Profile Visualized Intraluminal Support (LVIS) and LVIS Jr. Normal 180 Day Track QCA Intracranial Coil-Assist Stent Unknown
2021-07-16 P180027-S003 Flow Re-Direction Endoluminal Device (FRED®) System Real-Time Process OUT — —
2021-07-16 P170032-S007 Woven EndoBridge Aneurysm Embolization (WEB) System Real-Time Process OPR Intrasaccular Flow Disruption Device Unknown
2021-07-16 P170013-S006 Low-Profile Visualized Intraluminal Support (LVIS) and LVIS Jr. Real-Time Process QCA Intracranial Coil-Assist Stent Unknown
2021-06-01 P170032-S008 Woven EndoBridge (WEB) Aneurysm Embolization System 30-Day Notice OPR Intrasaccular Flow Disruption Device Unknown
2021-05-25 P180027-S004 Flow Re-Direction Endoluminal Device (FRED) System 30-Day Notice OUT — —
2021-03-29 P170032-S001 Woven EndoBridge (WEB) Aneurysm Embolization System Normal 180 Day Track No User Fee OPR Intrasaccular Flow Disruption Device Unknown
2021-02-25 P170013-S003 Low-Profile Visualized Intraluminal Support (LVIS) and LVIS Jr. Normal 180 Day Track No User Fee QCA Intracranial Coil-Assist Stent Unknown
2021-01-11 P170032-S004 Woven EndoBridge (WEB) Aneurysm Embolization System (WEB 017) Normal 180 Day Track OPR Intrasaccular Flow Disruption Device Unknown
2020-11-17 P170013-S001 LVIS and LVIS Jr. Normal 180 Day Track No User Fee QCA Intracranial Coil-Assist Stent Unknown
2020-07-17 P180027-S001 Flow Re-Direction Endoluminal Device (FRED) System 30-Day Notice OUT — —
2020-04-28 P170032-S006 Woven EndoBridge (WEB) Aneurysm Embolization System 30-Day Notice OPR Intrasaccular Flow Disruption Device Unknown
2020-02-07 P170032-S003 Woven EndoBridge (WEB) Aneurysm Embolization System Normal 180 Day Track OPR Intrasaccular Flow Disruption Device Unknown
2020-01-23 P170032-S005 Woven EndoBridge (WEB) Aneurysm Embolization System 30-Day Notice OPR Intrasaccular Flow Disruption Device Unknown
Safety

Recalls (14)

Class I (serious)
0
Risk of injury / death
Total recalls
14
Currently ongoing
10
Most recent
2026-04-06
DateSeverityStatusRecall # ProductCodeReason
2026-04-06 Class II Ongoing Z-2200-2026 LVIS Intraluminal Support Device, REF/Outside Diameter(OD)xTotal Length(TL)xWorking Length(WL): 214022-CAS/4.0 mm x 22 m… — Stent-assisted coiling device may due to commingling during manufacturing have dimensional nonconformance and/or incorrect device configuration. If device is ov…
2025-09-05 Class II Ongoing Z-0108-2026 Flow Re-Direction Endoluminal Devices: FRED 27, REF: FRED5019, FRED5029, FRED4528, FRED4026, FRED5526, FRED4508, FRED551… — Flow diverter may have a manufacturing issue related to the tantalum length and/or tantalum attachment pattern, which may lead the device to be incompletely ope…
2025-05-29 Class II Ongoing Z-2188-2025 LIFEPEARL Drug Elutable Microspheres: 200 +/- 50 micrometers, REF: 8LP2S200; 400 +/- 50 micrometers, REF: 8LP2S400 — Drug Elutable Microspheres have a smaller actual average diameter that is not within specification, which may lead to inability to reach the desired treatment l…
2024-12-11 Class II Ongoing Z-1121-2025 MicoVention Terumo, LVIS Intraluminal Support Device, REF: 213522-CAS, od, 3.5 mm, TL 22 mm, WL 18 mm, Sterile R, CE0297… — Potential for Polytetrafluoethylene (PTFE) material encasing the stent loop may prevent the stent from being pushed out of the introducer.
2024-12-02 Class II Ongoing Z-0990-2025 Microvention, Headway" 17 Advanced Straight Microcatheter with Hydrophilic Coating, REF: MC172150SX-CN, Sterile R, Rx On… — Sterility assurance; microcatheter inner packaging may contain incomplete seal.
2024-08-05 Class II Ongoing Z-3157-2024 ERIC Retrieval Device REF: ER173020 ER174030 ER176044 The ERIC Retrieval Device is a mechanical thrombectomy devi… — Due to Retrieval Device product labels stating the incorrect expiration dates that (5 years instead of 3 years) which extends beyond their true expiration date.
2023-12-21 Class II Ongoing Z-0868-2024 TERUMO HydroPearl Compressible Microspheres for Embolisation REF 8HP2S600 — Due to, during the manufacturing process, the prescribed manufacturing and quality processes were not followed and the product was inadvertently distributed.
2023-08-24 Class II Ongoing Z-0187-2024 AZUR CX 35 Peripheral Coil System Detachable 13mm x 24 CM, REF: 45-751324 — Peripheral coil system detachable has a potential of unsealed pouch packaging.
2023-06-07 Class II Ongoing Z-2238-2023 FRED Flow Re-Direction Endoluminal Device, REF: FRED3507-PMA, FRED3511, FRED3511-PMA, FRED3516-CA, FRED3516-PMA, FRED352… — Intracranial aneurysm flow diverter device may be manufactured with an incorrect inner stent length and may not perform as intended.
2022-09-21 Class II Ongoing Z-0170-2023 WEB Detachment Controller, REF: WDC-2, WDC, MV-WDC2. Component of WEB Aneurysm Embolization System. — Detachment controller, of an aneurysm embolization system, has an out of specification tunnel opening dimension, which may prevent the implant device pusher fro…
2021-10-20 Class II Terminated Z-0202-2022 Aspiration Syringe Kit, REF: MVSK60 — Syringe Kits labeled for distribution OUS were inadvertently shipped to US customers.
2021-04-21 Class III Terminated Z-1830-2021 VIA Microcatheter VIA 27 REF VIA-27-154-01 - Product Usage: is a single lumen catheter designed to be introduced over a … — Due to inadvertently shipping to U.S. customers with international labeling which has some differences with US-cleared labeling.
2021-04-21 Class III Terminated Z-1829-2021 VIA Microcatheter VIA 21 REF VIA-21-154-01 - Product Usage: is a single lumen catheter designed to be introduced over a … — Due to inadvertently shipping to U.S. customers with international labeling which has some differences with US-cleared labeling.
2021-04-21 Class III Terminated Z-1828-2021 VIA Microcatheter VIA 17 REF VIA-17-154-01 - Product Usage: is a single lumen catheter designed to be introduced over a … — Due to inadvertently shipping to U.S. customers with international labeling which has some differences with US-cleared labeling.
Filings

All 510(k) clearances (13)

Date K-number Device Code Class Specialty
2025-06-13 K243638 MV Flow Aspiration Pump (MVFLOWPMP01) JCX Class II General, Plastic Surgery
2024-05-16 K232542 Wedge XL Delivery Catheter QJP — —
2023-09-14 K230775 SOFIA EX Intracranial Support Catheter QJP — —
2023-04-27 K222694 EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190) NTE — —
2023-01-10 K222115 ISAAC Neurovascular Navigation Catheter DQY — —
2022-12-21 K223050 AZUR HydroPack 18 (45-880005; 45-880010; 45-880020; 45-880035; 45-880050; 45-880060) KRD — —
2022-09-12 K214024 SOFIA 88 Catheter DQY — —
2022-03-31 K211120 ERIC Retrieval Device NRY Class II Cardiovascular
2020-07-21 K193607 BOBBY Balloon Guide Catheter DQY — —
2020-07-02 K201487 Traxcess 7 Mini Guidewire MOF — —
2020-04-16 K200547 Traxcess 14 SELECT Guidewire MOF — —
2020-03-20 K191680 AZUR Vascular Plug KRD — —
2020-01-22 K192684 HydroPearl Microspheres NOY — —
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence