ARTERIAL BLOOD FILTER AF-1025-AF-1025BL— 510(k) K830131

Name: FDA 510(k) clearance K830131
Creator: U.S. Food and Drug Administration
Published: 1983-01-28

Substantially Equivalent

American Bentley

FDA 510(k) clearance K830131 for ARTERIAL BLOOD FILTER AF-1025-AF-1025BL, Substantially Equivalent on 1983-01-28. 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: 1983-01-12
Decision date: 1983-01-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.