Cleared Traditional

AFFINITY AF100 ARTERIAL FILTER WITH BALANCE BIOSURFACE

K122760 · Medtronic, Inc. · Cardiovascular
Dec 2012
Decision
88d
Days
Class 2
Risk

About This 510(k) Submission

K122760 is an FDA 510(k) clearance for the AFFINITY AF100 ARTERIAL FILTER WITH BALANCE BIOSURFACE, a Filter, Blood, Cardiopulmonary Bypass, Arterial Line (Class II — Special Controls, product code DTM), submitted by Medtronic, Inc. (Minneapolis, US). The FDA issued a Cleared decision on December 7, 2012, 88 days after receiving the submission on September 10, 2012. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4260.

Submission Details

510(k) Number K122760 FDA.gov
FDA Decision Cleared SESE
Date Received September 10, 2012
Decision Date December 07, 2012
Days to Decision 88 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DTM — Filter, Blood, Cardiopulmonary Bypass, Arterial Line
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.4260

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