Chrysalis Intelligence · Sponsors · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular

Micro Therapeutics, Inc. d/b/a ev3 Neurovascular

Irvine, CA, US · 12 510(k) clearances · 30 PMAs

Total clearances
12
2020-01-18 → 2025-01-02
Last 12 months
0
Product codes
9
Most recent
2025-01-02
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
NRY Catheter, Thrombus Retriever Class II Cardiovascular 2 2024-10-29
POL 2 2021-03-01
DQX Wire, Guide, Catheter Class II Cardiovascular 2 2020-07-21
QJP 1 2025-01-02
JCX Apparatus, Suction, Ward Use, Portable, Ac-Powered Class II General, Plastic Surgery 1 2024-12-02
DQY 1 2021-07-27
HCG 1 2021-07-07
KRD 1 2021-02-09
KRA 1 2020-09-14
Class III

PMA approvals (30)

Total PMA records
30
Originals + supplements
Distinct product codes
1
First decision
2020-06-29
Most recent
2026-07-21
DatePMA #Trade nameTypeCodeDevice nameSpecialty
2026-07-21 P100018-S055 Pipeline™ Flex Embolization Device (Pipeline™ Flex); Pipeline™ Flex Embolization Device with Shield Technology™ (Pipelin 30-Day Notice OUT
2026-06-26 P100018-S054 Pipeline™ Flex Embolization Device with Shield Technology™ (Pipeline™ Shield); Pipeline™ Vantage Embolization Device wit 30-Day Notice OUT
2026-05-15 P100018-S053 Pipeline™ Flex Embolization Device (Pipeline™ Flex); Pipeline™ Flex Embolization Device with Shield Technology™ (Pipelin 30-Day Notice OUT
2026-02-20 P100018-S052 PIPELINE EMBOLIZATION DEVICE Real-Time Process OUT
2025-08-14 P100018-S048 Pipeline™ Vantage Embolization Device with Shield Technology™ Normal 180 Day Track No User Fee OUT
2025-06-04 P100018-S051 Pipeline™ Flex Embolization Device (Pipeline™ Flex); Pipeline™ Flex Embolization Device with Shield Technology™ (Pipelin 30-Day Notice OUT
2025-03-27 P100018-S050 Pipeline Flex Embolization Device; Pipeline Flex Embolization Device with Shield Technology (Pipeline™ Shield) 30-Day Notice OUT
2025-03-05 P100018-S049 Pipeline™ Vantage Embolization Device with Shield Technology™ (Pipeline™ Vantage) Special (Immediate Track) OUT
2024-09-20 P100018-S047 Pipeline™ Flex Embolization Device with Shield Technology™, Pipeline™ Vantage Embolization Device with Shield Technology 30-Day Notice OUT
2024-07-26 P100018-S046 Pipeline™ Flex Embolization Device with Shield Technology™, Pipeline™ Vantage Embolization Device with Shield Technology 30-Day Notice OUT
2024-06-06 P100018-S043 Pipeline™ Vantage Embolization Device with Shield Technology™ Normal 180 Day Track No User Fee OUT
2024-04-25 P100018-S044 Pipeline™ Flex Embolization Device with Shield Technology™ (PED2), Pipeline™ Vantage Embolization Device with Shield Tec Real-Time Process OUT
2023-10-25 P100018-S042 Pipeline Vantage Embolization Device with Shield Technology 30-Day Notice OUT
2023-10-10 P100018-S041 Pipeline™ Flex Embolization Device, Pipeline™ Flex Embolization Device with Shield Technology™ 30-Day Notice OUT
2023-09-15 P100018-S034 Pipeline Vantage Embolization Device with Shield Technology Normal 180 Day Track OUT
2023-09-06 P100018-S040 Pipeline™ Flex Embolization Device, Pipeline™ Flex Embolization Device with Shield Technology™ 30-Day Notice OUT
2023-03-16 P100018-S039 Pipeline™ Flex with Shield Technology™ 30-Day Notice OUT
2023-02-28 P100018-S038 Pipeline Flex Embolization Device, Pipeline Flex Embolization Device with Shield Technology 30-Day Notice OUT
2022-11-02 P100018-S037 Pipeline™ Flex Embolization Device and Pipeline™ Flex Embolization Device with Shield Technology™ Real-Time Process OUT
2022-02-08 P100018-S035 Pipeline™ Flex, Pipeline™ Flex with Shield Technology™ Real-Time Process OUT
2021-12-27 P100018-S036 Pipeline™ Flex Embolization Device, Pipeline™ Flex Embolization Device with Shield Technology™ 30-Day Notice OUT
2021-07-27 P100018-S033 Pipeline Flex Embolization Device and Pipeline Flex Embolization Device with Shield Technology 30-Day Notice OUT
2021-07-19 P100018-S032 Pipeline Flex Embolization Device with Shield Technology Normal 180 Day Track No User Fee OUT
2021-04-29 P100018-S029 Pipeline Flex Embolization Device Normal 180 Day Track OUT
2021-04-13 P100018-S026 Pipeline Flex Embolization Device with Shield Technology Normal 180 Day Track OUT
2021-02-26 P100018-S031 Pipeline Flex Embolization Device 30-Day Notice OUT
2020-12-21 P100018-S030 Pipeline Flex Embolization Device 30-Day Notice OUT
2020-10-05 P100018-S024 Pipeline Flex Embolization Device Normal 180 Day Track No User Fee OUT
2020-09-21 P100018-S028 Pipeline Flex Embolization Device Special (Immediate Track) OUT
2020-06-29 P100018-S027 Pipeline Flex Embolization Device 30-Day Notice OUT
Filings

All 510(k) clearances (12)

Date K-number Device Code Class Specialty
2025-01-02 K241388 Rist 079 Radial Access Guide Catheter; Rist 071 Radial Access Guide Catheter; Rist Radial Access Selective Catheter QJP
2024-12-02 K243418 Riptide™ Aspiration Pump; Riptide™ Collection Canister with Intermediate Tubing JCX Class II General, Plastic Surgery
2024-10-29 K243080 Riptide Aspiration System NRY Class II Cardiovascular
2021-07-27 K211990 Rist 071 Radial Access Guide Catheter DQY
2021-07-07 K203432 Axium Detachable Coil; Axium Prime Detachable Coil HCG
2021-03-01 K203358 Solitaire X Revascularization Device POL
2021-02-09 K202850 Concerto Versa, Detachable Coil KRD
2020-11-20 K193576 Solitaire Platinum Revascularization Device, Solitaire X Revascularization Device (Solitaire Revascularization Device) POL
2020-09-14 K202318 Marathon Flow Directed Micro Catheter KRA
2020-07-21 K201690 Mirage Hydrophilic Guidewire; X-pedion Hydrophilic Guidewire DQX Class II Cardiovascular
2020-07-21 K201689 Riptide Aspiration System NRY Class II Cardiovascular
2020-01-18 K193548 Mirage Hydrophilic Guidewire, X-pedion Hydrophilic Guidewire DQX Class II Cardiovascular