ORTHOFUSER WOUND DRAINAGE/AUTOTRANSFUSION SYSTEM— 510(k) K912019

Name: FDA 510(k) clearance K912019
Creator: U.S. Food and Drug Administration
Published: 1991-10-08

Substantially Equivalent

Gish Biomedical, Inc.

FDA 510(k) clearance K912019 for ORTHOFUSER WOUND DRAINAGE/AUTOTRANSFUSION SYSTEM, Substantially Equivalent on 1991-10-08. Applicant: Gish Biomedical, Inc.. Device class: 2.

Clearance details

Applicant: Gish Biomedical, Inc.
Product code: Code CAC
Device class: Class 2
Regulation: 21 CFR 868.5830
Advisory panel: Anesthesiology
Date received: 1991-05-07
Decision date: 1991-10-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, CA, US

Download summary PDF View on FDA.gov ↗

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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.