JODClass II
Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass
Cardiovascular · 21 CFR 870.4270
MDR events8All time
Recalls0All time
Registered firms10Currently listed
510(k) clearances12All time
Recent MDR events
8 adverse event reports on file
- D733 MICRO 40 PH.I.S.O. ARTERIAL FILTERDec 28, 2015MalfunctionSorin Group Italia9680841-2015-00632
- SORINGROUPApr 2, 2012OtherSorin Group Usa2518155
- PALL CARDIOPLEGIA PLUS FILTER WITH SOLUTION SPIKEJun 18, 2008MalfunctionPall Life Sciences Puerto Rico, Llc2647898-2008-00002
- FALL CARDIOPLEGIA PLUS FILTER WITH SOLUTION SPIKEJun 20, 2007MalfunctionPall Life Sciences Puerto Rico, Llc2647898-2007-00010
- PALL CARDIOPLEGIA PLUS FILTER W/SOLUTION SPIKEMay 4, 2007MalfunctionPall Biomedical, Inc.2647898-2007-00009
- PALL CARDIOPLEGIA PLUS FILTER W/SOLUTION SPIKEMay 3, 2007MalfunctionPall Biomedical, Inc.2647898-2007-00008
- PALL CARDIOGPLEGIA PLUS FILTER WITH POSIDYNE MEMBRANEOct 5, 2006MalfunctionPall Biomedical, Inc.2647898-2006-00006
- MEDTRONIC INTERSEPT 1351/CBNov 17, 2001DeathMetronic Af BusinessMW4003140
Event type breakdown
Malfunction6
Death1
Other1
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
10 firms currently registered for this product code
510(k) clearances
12 clearances for this product code
- Olson Medical Sales, Inc.Mar 28, 2000
K993060 · GAS FILTER
- Gish Biomedical, Inc.Mar 10, 1989
K890504 · CARDIOTOMY/AUTOTRANSFUSION/PLEURAL DRAINAGE VENOUS
- Pall Biomedical Products Co.Feb 29, 1988
K875095 · PALL CARDIOPLEGIA PLUS FILTER W/POSIDYNE MEMBRANE
- Pall Biomedical Products Co.Dec 30, 1987
K874405 · PALL STAT PRIME(TM) BLOOD FILTER FOR EXTRA. USE
- Cobe Laboratories, Inc.Feb 26, 1986
K855067 · SWANK CARDIOTOMY SUCTION LINE BLOOD FILTER CA100
- Sterile Design, Inc.Oct 15, 1984
K841958 · CARDIO METRICS CARDIOTOMY RESERVOIR
- Texas Medical Products, Inc.Jun 30, 1983
K830634 · CARDIOTOMY FILTER
- Medical, Inc.Nov 24, 1982
K823259 · INTERFACE CARDIOTOMY BLOOD FILTER #50