CARDIOTOMY/AUTOTRANSFUSION/PLEURAL DRAINAGE VENOUS— 510(k) K890504

Name: FDA 510(k) clearance K890504
Creator: U.S. Food and Drug Administration
Published: 1989-03-10

Substantially Equivalent

Gish Biomedical, Inc.

FDA 510(k) clearance K890504 for CARDIOTOMY/AUTOTRANSFUSION/PLEURAL DRAINAGE VENOUS, Substantially Equivalent on 1989-03-10. Applicant: Gish Biomedical, Inc.. Device class: 2.

Clearance details

Applicant: Gish Biomedical, Inc.
Product code: Code JOD
Device class: Class 2
Regulation: 21 CFR 870.4270
Advisory panel: Cardiovascular
Date received: 1989-02-01
Decision date: 1989-03-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, CA, US

Download summary PDF View on FDA.gov ↗

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