INARI MEDICAL

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
56
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2299-2020Class IITriever20 Aspiration Guide Catheter a component of FlowTriever Retrieval/ Aspiration System, UDI: 00March 23, 2020

Recent 510(k) Clearances

K-NumberDeviceDate
K252508Intri26 Introducer SheathDecember 17, 2025
K253323Protrieve SheathOctober 29, 2025
K250421InThrill™ Thrombectomy SystemMay 12, 2025
K250088FlowTriever2 CatheterMarch 13, 2025
K241894Artix™ MT; Artix™ Thin-Walled Thrombectomy SheathOctober 15, 2024
K242557ClotTriever XL Catheter (41-102)September 27, 2024
K233069Removal System Large Bore 60 cc SyringeMarch 26, 2024
K234034VenaCore Thrombectomy Catheter (46-101)February 9, 2024
K233815ClotTriever SheathDecember 18, 2023
K233646Intri24 Introducer Sheath (52-101)December 12, 2023
K231108Talon Transseptal SheathSeptember 27, 2023
K231848Triever20 Curve (21-201)July 21, 2023
K231782FlowSaver Blood Return System (80-101)July 14, 2023
K230912Artix BGMay 2, 2023
K223210ClotTriever XL CatheterApril 27, 2023
K230494ClotTriever BOLD CatheterApril 18, 2023
K223419Triever16 CurveMarch 23, 2023
K223613InThrill Thrombectomy SystemMarch 17, 2023
K223609RevCore™ Thrombectomy Catheter.March 14, 2023
K230331Protrieve SheathMarch 7, 2023