CELL SAVER 5 SYSTEM— 510(k) K932890

Name: FDA 510(k) clearance K932890
Creator: U.S. Food and Drug Administration
Published: 1994-01-05

Substantially Equivalent

Haemonetics Corp.

FDA 510(k) clearance K932890 for CELL SAVER 5 SYSTEM, Substantially Equivalent on 1994-01-05. Applicant: Haemonetics Corp.. Device class: 2.

Clearance details

Applicant: Haemonetics Corp.
Product code: Code CAC
Device class: Class 2
Regulation: 21 CFR 868.5830
Advisory panel: Anesthesiology
Date received: 1993-06-14
Decision date: 1994-01-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Braintree, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CAC

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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
K231782 — FlowSaver Blood Return System (80-101)2023-07-14
K221483 — FlowSaver Blood Return System2023-02-17

More clearances from Haemonetics Corp.

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K122262 — ORTHOPAT ADVANCE PERIOPERATIVE AUTOTRANSFUSION SYSTEM2012-10-25
K120586 — CELL SAVER ELITE2012-05-22
K101907 — HAEMONETICS CELL SAVER ELITE AUTOTRANSFUSION SYSTEM2010-12-03
K062801 — SMARTSUCTION SOLO DEVICE2006-10-04
K061103 — HAEMONETICS 40U RBC FILTER BAG2006-05-17

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 →

Recalls naming K932890

K-number listed on FDA's recall record

Z-0885-2020 — CS5/5+ Fastpacks, 225 mL, 150¿ Res Autotransfusion Device - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma.Class II·Terminated·Haemonetics Corporation·20191021
Z-0886-2020 — CS5/5+ Bowl Kit-125 mL Autotransfusion Device - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma.Class II·Terminated·Haemonetics Corporation·20191021
Z-0887-2020 — High Speed Cell Saver¿5/5+ Bowl Set Autotransfusion Device - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma.Class II·Terminated·Haemonetics Corporation·20191021
Z-0888-2020 — CS5/5+ Fastpacks, 125 mL, 150¿ Res Autotransfusion Device - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma.Class II·Terminated·Haemonetics Corporation·20191021
Z-0889-2020 — CS5/5+ Fastpacks, 125 mL, 20¿ Res Autotransfusion Device- Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma.Class II·Terminated·Haemonetics Corporation·20191021
Z-0890-2020 — CS5/5+ Fastpacks, 225 mL, 20¿ Res Autotransfusion Device - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma.Class II·Terminated·Haemonetics Corporation·20191021
Z-0891-2020 — Cell Saver¿5/5+ Bowl Kit (225 ml) Autotransfusion Device - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma.Class II·Terminated·Haemonetics Corporation·20191021

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K932890.

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