HEPARIN COATED ARTERIAL BLOOD FILTERS— 510(k) K842813

Name: FDA 510(k) clearance K842813
Creator: U.S. Food and Drug Administration
Published: 1985-01-08

Substantially Equivalent

American Bentley

FDA 510(k) clearance K842813 for HEPARIN COATED ARTERIAL BLOOD FILTERS, Substantially Equivalent on 1985-01-08. Applicant: American Bentley. Device class: 2.

Clearance details

Applicant: American Bentley
Product code: Code DTM
Device class: Class 2
Regulation: 21 CFR 870.4260
Advisory panel: Cardiovascular
Date received: 1984-07-18
Decision date: 1985-01-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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