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510(k) K231782

FlowSaver Blood Return System (80-101) by Inari Medical, Inc. — Product Code CAC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 14, 2023
Date Received
June 16, 2023
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Autotransfusion
Device Class
Class II
Regulation Number
868.5830
Review Panel
CV
Submission Type

Other clearances by Inari Medical, Inc.

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  • K250421 — InThrill™ Thrombectomy System (May 12, 2025)
  • K250088 — FlowTriever2 Catheter (March 13, 2025)
  • K241894 — Artix™ MT; Artix™ Thin-Walled Thrombectomy Sheath (October 15, 2024)
  • K242557 — ClotTriever XL Catheter (41-102) (September 27, 2024)
  • K233069 — Removal System Large Bore 60 cc Syringe (March 26, 2024)
  • K234034 — VenaCore Thrombectomy Catheter (46-101) (February 9, 2024)
  • K233815 — ClotTriever Sheath (December 18, 2023)
  • K233646 — Intri24 Introducer Sheath (52-101) (December 12, 2023)

Other clearances for product code CAC

  • K241236 — XTRA Collection sets; XTRA Sequestration set X (August 16, 2024)
  • K240426 — Aventus Clot Management System (May 14, 2024)
  • K240584 — XTRA Autotransfusion System (with XTRA Bowl sets) (April 29, 2024)
  • K221483 — FlowSaver Blood Return System (February 17, 2023)
  • K221722 — Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US) (November 15, 2022)
  • K201305 — Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suc (September 3, 2021)
  • K210862 — Hemafuse System (July 29, 2021)
  • K210176 — FlowSaver Blood Filter (July 22, 2021)
  • K210089 — CATSmart, Automated Blood Processing Autotransfusion System (February 11, 2021)
  • K193361 — ProCell Surgical Sponge-Blood Recovery Unit (June 1, 2020)