Cleared Traditional

VENOUS BUBBLE TRAP, MODEL VBT 160; VENOUS BUBBLE TRAP WITH BIOLINE COATING, MODEL BE-VBT 160, BEQ-VBT 160

K082412 · Mapquet Cardiopulmonary AG · Cardiovascular
Nov 2008
Decision
81d
Days
Class 2
Risk

About This 510(k) Submission

K082412 is an FDA 510(k) clearance for the VENOUS BUBBLE TRAP, MODEL VBT 160; VENOUS BUBBLE TRAP WITH BIOLINE COATING, MODEL BE-VBT 160, BEQ-VBT 160, a Defoamer, Cardiopulmonary Bypass (Class II — Special Controls, product code DTP), submitted by Mapquet Cardiopulmonary AG (Hirrlingen, DE). The FDA issued a Cleared decision on November 10, 2008, 81 days after receiving the submission on August 21, 2008. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4230.

Submission Details

510(k) Number K082412 FDA.gov
FDA Decision Cleared SESE
Date Received August 21, 2008
Decision Date November 10, 2008
Days to Decision 81 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
AFFINITY VARD SUB-ASSEMBLY FOR CPS (CARMEDA COATED), PURGELINE (UNCOATED), HOLDING BAG
K101186 · Medtronic Perfusion Systems · Sep 2010
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