ARTERIAL FILTER AFS-XX /FILTER HOLDER AFS-HXX— 510(k) K851003

Name: FDA 510(k) clearance K851003
Creator: U.S. Food and Drug Administration
Published: 1985-07-29

Substantially Equivalent

Gish Biomedical, Inc.

FDA 510(k) clearance K851003 for ARTERIAL FILTER AFS-XX /FILTER HOLDER AFS-HXX, Substantially Equivalent on 1985-07-29. 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: 1985-03-12
Decision date: 1985-07-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, CA, US

Download summary PDF View on FDA.gov ↗

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