QUART ARTERIAL FILTER WITH BIOLINE COATING— 510(k) K082544

Name: FDA 510(k) clearance K082544
Creator: U.S. Food and Drug Administration
Published: 2008-10-03

Substantially Equivalent

Maquet Cardiopulmonary, AG

FDA 510(k) clearance K082544 for QUART ARTERIAL FILTER WITH BIOLINE COATING, Substantially Equivalent on 2008-10-03. Applicant: Maquet Cardiopulmonary, AG. Device class: 2.

Clearance details

Applicant: Maquet Cardiopulmonary, AG
Product code: Code DTM
Device class: Class 2
Regulation: 21 CFR 870.4260
Advisory panel: Cardiovascular
Date received: 2008-09-03
Decision date: 2008-10-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Hirrlingen, DE

Download summary PDF View on FDA.gov ↗

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