COBE AUTOLOGOUS BLOOD SALVAGE RESERV W/W/O FILTER— 510(k) K902671

Name: FDA 510(k) clearance K902671
Creator: U.S. Food and Drug Administration
Published: 1990-07-17

Substantially Equivalent

Cobe Laboratories, Inc.

FDA 510(k) clearance K902671 for COBE AUTOLOGOUS BLOOD SALVAGE RESERV W/W/O FILTER, Substantially Equivalent on 1990-07-17. Applicant: Cobe Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Cobe Laboratories, Inc.
Product code: Code CAC
Device class: Class 2
Regulation: 21 CFR 868.5830
Advisory panel: Anesthesiology
Date received: 1990-06-18
Decision date: 1990-07-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arvada, CO, US

Download summary PDF View on FDA.gov ↗

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K923272 — COBE CMS-HF HOLLOW FIBER MEMBRANE OXYGENATOR1993-05-11
K900105 — COBE SPECTRA BLOOD COMPONENT SEPARATOR THERAPEUTIC1991-03-22
K905793 — COBE CENTRY 2 BICART OPTION KIT1991-02-12
K905388 — COBE CENTRYSYSTEM 3 BICART OPTION KIT1991-02-11
K904336 — NEW COBE SATURATION/HEMATOCRIT MONITOR1990-12-27

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.