PEDIATRIC ARTERIAL BLOOD FILTER— 510(k) K840612

Name: FDA 510(k) clearance K840612
Creator: U.S. Food and Drug Administration
Published: 1984-04-17

Substantially Equivalent

American Bentley

FDA 510(k) clearance K840612 for PEDIATRIC ARTERIAL BLOOD FILTER, Substantially Equivalent on 1984-04-17. 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: 1984-02-13
Decision date: 1984-04-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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