Cleared Traditional

JOSTRA HLM TUBING SET

K053025 · Maquet Cardiopulmonary, AG · Cardiovascular
Nov 2005
Decision
14d
Days
Class 2
Risk

About This 510(k) Submission

K053025 is an FDA 510(k) clearance for the JOSTRA HLM TUBING SET, a Tubing, Pump, Cardiopulmonary Bypass (Class II — Special Controls, product code DWE), submitted by Maquet Cardiopulmonary, AG (Fairfield, US). The FDA issued a Cleared decision on November 10, 2005, 14 days after receiving the submission on October 27, 2005. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4390.

Submission Details

510(k) Number K053025 FDA.gov
FDA Decision Cleared SESE
Date Received October 27, 2005
Decision Date November 10, 2005
Days to Decision 14 days
Submission Type Traditional
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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