GISH ARTERIAL FILTER WITH GBS COATING— 510(k) K023833

Name: FDA 510(k) clearance K023833
Creator: U.S. Food and Drug Administration
Published: 2003-03-31

Substantially Equivalent

Gish Biomedical, Inc.

FDA 510(k) clearance K023833 for GISH ARTERIAL FILTER WITH GBS COATING, Substantially Equivalent on 2003-03-31. Applicant: Gish Biomedical, Inc.. Device class: 2.

Clearance details

Applicant: Gish Biomedical, Inc.
Product code: Code DTM
Device class: Class 2
Regulation: 21 CFR 870.4260
Advisory panel: Cardiovascular
Date received: 2002-11-18
Decision date: 2003-03-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, US

Download summary PDF View on FDA.gov ↗

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