Cleared Special

HLM TUBING SET WITH BIOLINE COATING

K080592 · Maquet Cardiopulmonary, AG · Cardiovascular
Sep 2008
Decision
192d
Days
Class 2
Risk

About This 510(k) Submission

K080592 is an FDA 510(k) clearance for the HLM TUBING SET WITH BIOLINE COATING, a Tubing, Pump, Cardiopulmonary Bypass (Class II — Special Controls, product code DWE), submitted by Maquet Cardiopulmonary, AG (Hirrlingen, DE). The FDA issued a Cleared decision on September 11, 2008, 192 days after receiving the submission on March 3, 2008. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4390.

Submission Details

510(k) Number K080592 FDA.gov
FDA Decision Cleared SESE
Date Received March 03, 2008
Decision Date September 11, 2008
Days to Decision 192 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DWE — Tubing, Pump, Cardiopulmonary Bypass
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.4390

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