FlowSaver Blood Return System (80-101)— 510(k) K231782

Name: FDA 510(k) clearance K231782
Creator: U.S. Food and Drug Administration
Published: 2023-07-14

Substantially Equivalent

Inari Medical, Inc.

FDA 510(k) clearance K231782 for FlowSaver Blood Return System (80-101), Substantially Equivalent on 2023-07-14. Applicant: Inari Medical, Inc.. Device class: 2.

Clearance details

Applicant: Inari Medical, Inc.
Product code: Code CAC
Device class: Class 2
Regulation: 21 CFR 868.5830
Advisory panel: Anesthesiology
Date received: 2023-06-16
Decision date: 2023-07-14
Decision: Substantially Equivalent
Clearance type: Special
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CAC

view all

K241236 — XTRA Collection sets; XTRA Sequestration set X2024-08-16
K240426 — Aventus Clot Management System2024-05-14
K240584 — XTRA Autotransfusion System (with XTRA Bowl sets)2024-04-29
K221483 — FlowSaver Blood Return System2023-02-17
K221722 — Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)2022-11-15

More clearances from Inari Medical, Inc.

view all

K262538 — Artix MT; Artix Thin-Walled Sheath2026-08-21
K252508 — Intri26 Introducer Sheath2025-12-17
K250421 — InThrill Thrombectomy System2025-05-12
K250088 — FlowTriever2 Catheter2025-03-13
K241894 — Artix MT; Artix Thin-Walled Thrombectomy Sheath2024-10-15

Adverse events under product code CAC

product code CAC

Death: 11
Malfunction: 477
Total: 488

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.