Chrysalis Intelligence · Sponsors · Inari Medical, Inc.

Inari Medical, Inc.

Irvine, CA, US · 39 510(k) clearances · 1 recalls

← Library Overview New Filings 510(k) Explorer Recalls Explorer All Sponsors All Product Codes Orphan Products Signals
Total clearances
39
2020-09-09 → 2025-12-17
Last 12 months
2
Product codes
5
Most recent
2025-12-17
Name variants in FDA filings: Inari Medical / Inari Medical, Inc.
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
QEW Peripheral Mechanical Thrombectomy With Aspiration Class II Cardiovascular 30 2025-10-29
DYB Introducer, Catheter Class II Cardiovascular 4 2025-12-17
CAC Apparatus, Autotransfusion Class II Anesthesiology 3 2023-07-14
PUR Vacuum Syringe Class II General Hospital 1 2024-03-26
DQY — — — 1 2022-07-11
Safety

Recalls (1)

Class I (serious)
0
Risk of injury / death
Total recalls
1
Currently ongoing
0
Most recent
2020-03-23
DateSeverityStatusRecall # ProductCodeReason
2020-03-23 Class II Terminated Z-2299-2020 Triever20 Aspiration Guide Catheter a component of FlowTriever Retrieval/ Aspiration System, UDI: 00850291007079 — The hemostasis valve of aspiration guide catheter devices may fail to seal resulting in a loss of vacuum during thrombus aspiration, which may result the proced…
Filings

All 510(k) clearances (39)

Date K-number Device Code Class Specialty
2025-12-17 K252508 Intri26 Introducer Sheath DYB Class II Cardiovascular
2025-10-29 K253323 Protrieve Sheath QEW Class II Cardiovascular
2025-05-12 K250421 InThrill™ Thrombectomy System QEW Class II Cardiovascular
2025-03-13 K250088 FlowTriever2 Catheter QEW Class II Cardiovascular
2024-10-15 K241894 Artix™ MT; Artix™ Thin-Walled Thrombectomy Sheath QEW Class II Cardiovascular
2024-09-27 K242557 ClotTriever XL Catheter (41-102) QEW Class II Cardiovascular
2024-03-26 K233069 Removal System Large Bore 60 cc Syringe PUR Class II General Hospital
2024-02-09 K234034 VenaCore Thrombectomy Catheter (46-101) QEW Class II Cardiovascular
2023-12-18 K233815 ClotTriever Sheath QEW Class II Cardiovascular
2023-12-12 K233646 Intri24 Introducer Sheath (52-101) DYB Class II Cardiovascular
2023-09-27 K231108 Talon Transseptal Sheath DYB Class II Cardiovascular
2023-07-21 K231848 Triever20 Curve (21-201) QEW Class II Cardiovascular
2023-07-14 K231782 FlowSaver Blood Return System (80-101) CAC Class II Anesthesiology
2023-05-02 K230912 Artix BG QEW Class II Cardiovascular
2023-04-27 K223210 ClotTriever XL Catheter QEW Class II Cardiovascular
2023-04-18 K230494 ClotTriever BOLD Catheter QEW Class II Cardiovascular
2023-03-23 K223419 Triever16 Curve QEW Class II Cardiovascular
2023-03-17 K223613 InThrill Thrombectomy System QEW Class II Cardiovascular
2023-03-14 K223609 RevCore™ Thrombectomy Catheter. QEW Class II Cardiovascular
2023-03-07 K230331 Protrieve Sheath QEW Class II Cardiovascular
2023-03-02 K223436 Artix AX QEW Class II Cardiovascular
2023-02-17 K221483 FlowSaver Blood Return System CAC Class II Anesthesiology
2023-02-06 K221531 ClotTriever Thrombectomy System QEW Class II Cardiovascular
2023-01-11 K223000 Artix BG QEW Class II Cardiovascular
2022-08-04 K220887 Mini-ClotTriever Thrombectomy System QEW Class II Cardiovascular
2022-07-12 K220415 Protrieve Sheath QEW Class II Cardiovascular
2022-07-11 K221846 Artix Ballon Guiding Sheath DQY — —
2022-05-23 K213402 Triever24, Triever20 QEW Class II Cardiovascular
2022-04-01 K212392 Intri24 Sheath DYB Class II Cardiovascular
2022-03-25 K220600 Artix Thrombectomy Device QEW Class II Cardiovascular
2021-10-18 K212632 ClotTriever Thrombectomy System QEW Class II Cardiovascular
2021-07-22 K210176 FlowSaver Blood Filter CAC Class II Anesthesiology
2021-05-12 K210689 ClotTriever Thrombectomy System QEW Class II Cardiovascular
2021-04-30 K211013 FlowTriever Retrieval/Aspiration System, FlowTriever Catheters, Triever 16, Triever 20, Triever 20 Curve, Triever 24 QEW Class II Cardiovascular
2021-02-24 K210195 Triever Catheters QEW Class II Cardiovascular
2020-12-18 K202345 FlowTriever Retrieval/Aspiration System QEW Class II Cardiovascular
2020-12-10 K203333 Triever20 Curve Catheter QEW Class II Cardiovascular
2020-12-04 K201541 FlowTriever Retrieval/Aspiration System QEW Class II Cardiovascular
2020-09-09 K193462 ClotTriever Thrombectomy System QEW Class II Cardiovascular
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence