Cleared Traditional

AFFINITY VARD SUB-ASSEMBLY FOR CPS (CARMEDA COATED), PURGELINE (UNCOATED), HOLDING BAG

K101186 · Medtronic Perfusion Systems · Cardiovascular
Sep 2010
Decision
128d
Days
Class 2
Risk

About This 510(k) Submission

K101186 is an FDA 510(k) clearance for the AFFINITY VARD SUB-ASSEMBLY FOR CPS (CARMEDA COATED), PURGELINE (UNCOATED), HOLDING BAG, a Defoamer, Cardiopulmonary Bypass (Class II — Special Controls, product code DTP), submitted by Medtronic Perfusion Systems (Minneapolis, US). The FDA issued a Cleared decision on September 3, 2010, 128 days after receiving the submission on April 28, 2010. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4230.

Submission Details

510(k) Number K101186 FDA.gov
FDA Decision Cleared SESE
Date Received April 28, 2010
Decision Date September 03, 2010
Days to Decision 128 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DTP — Defoamer, Cardiopulmonary Bypass
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.4230

Similar Devices — DTP Defoamer, Cardiopulmonary Bypass

All 33
VENOUS BUBBLE TRAP, MODEL VBT 160; VENOUS BUBBLE TRAP WITH BIOLINE COATING, MODEL BE-VBT 160, BEQ-VBT 160
K082412 · Mapquet Cardiopulmonary AG · Nov 2008
COBE VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR, COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR
K004046 · Cobe Cardiovascular, Inc. · Apr 2001
COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR
K002591 · Cobe Cardiovascular, Inc. · Sep 2000
MODIFICATION OF BARD QUANTUM CVR, MODEL H-6770VR
K990514 · C.R. Bard, Inc. · Mar 1999
DIDECO D920, LILLIPUT 1 TWIN RESERVOIR
K984322 · Dideco S.P.A. · Mar 1999
BARD QUANTUM CVR
K962726 · C.R. Bard, Inc. · Oct 1996

More from Medtronic Perfusion Systems

View all
Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface (BB811); Affinity Fusion Oxygenator with Integrated Arterial Filter and Cardiotomy/Venous Reservoir with Balance Biosurface (BB841); Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface NON STERILE (BB811-NS)
K240666 · DTZ · Jul 2024
autoLog IQ Autotransfusion System
K181954 · CAC · Aug 2018
AFFINITY AF100 ARTERIAL FILTER WITH CARMEDA BIOACTIVE SURFACE
K123351 · DTM · Mar 2013
MIRCSP (MINIMALLY INVASIVE RETROGRADE CORONARY SINUS PERFUSION) MANUAL INFLATE CANNULA, MODEL 94113TD
K090869 · DWF · Aug 2009
BIO-CONSOLE 560
K080824 · DWA · May 2008