Defoamer, Cardiopulmonary Bypass
Cardiovascular · 21 CFR 870.4230
Recent MDR events
4 adverse event reports on file
- VENOUS BUBBLE TRAP (VBT)Jun 28, 2016InjuryMaquet Cardiopulmonary Ag8010762-2016-00413
- VENOUS BUBBLE TRAP WITH & W/O BIOLINE COATINGNov 26, 2014MalfunctionMaquet Cardiopulmoary Ag8010762-2014-00420
- BO-VBT 160-J#BO-VENOUS BUBBLE TRAP- STERILEAug 7, 2014MalfunctionMaquet Cardiopulmonary Ag8010762-2014-00295
- BO-VBT 160-J#BO-VENOUS BUBBLE TRAP- STERILEAug 7, 2014MalfunctionMaquet Cardiopulmonary Ag8010762-2014-00294
Event type breakdown
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
29 firms currently registered for this product code
Steril Verona Srl
Nogara Verona, IT
Sterigenics U.s., Llc
Queensbury, NY, US
Sterigenics Belgium Petit Rechain S.a.
Verviers Liege, BE
Sorin Group Italia S.r.l
MIRANDOLA Modena, IT
Novosci Corp.
Conroe, TX, US
Medtronic Perfusion Systems
Minneapolis, MN, US
Midwest Sterilization Corp.
JACKSON, MO, US
Medtronic Mexico S. De R.l. De Cv
Tijuana Baja California, MX
Terumo Cardiovascular Systems Corporation
ELKTON, MD, US
Dsv Contract Logistics
Tijuana Baja California, MX
Sterigenics Us Llc
Los Angeles, CA, US
Centerpiece S. De R.l De C.v (sterilization Site)
Tijuana Baja California, MX
Sterigenics U.s., Llc
Corona, CA, US
Isomedix Operations Inc
EL PASO, TX, US
510(k) clearances
34 clearances for this product code
- Medtronic Perfusion SystemsSep 3, 2010
K101186 · AFFINITY VARD SUB-ASSEMBLY FOR CPS (CARMEDA COATED), PURGELINE (UNCOATED), HOLDING BAG
- Mapquet Cardiopulmonary AGNov 10, 2008
K082412 · VENOUS BUBBLE TRAP, MODEL VBT 160; VENOUS BUBBLE TRAP WITH BIOLINE COATING, MODEL BE-VBT 160, BEQ-VBT 160
- Cobe Cardiovascular, Inc.Apr 26, 2001
K004046 · COBE VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR, COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR
- Cobe Cardiovascular, Inc.Sep 13, 2000
K002591 · COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR
- C.R. Bard, Inc.Mar 9, 1999
K990514 · MODIFICATION OF BARD QUANTUM CVR, MODEL H-6770VR
- Dideco S.P.A.Mar 2, 1999
K984322 · DIDECO D920, LILLIPUT 1 TWIN RESERVOIR
- C.R. Bard, Inc.Oct 30, 1996
K962726 · BARD QUANTUM CVR
- 3M Health Care, SarnsJul 26, 1994
K941654 · SARNS FILTERED VENOUS RESERVIOR MODIFICATION