Panels › Cardiovascular › Product code DTZ · Class 2
Oxygenator, Cardiopulmonary Bypass
Regulation 870.4350
5510(k)s in 12 months (255 all time)
0recalls in 12 months (107 all time)
98recalls that name a 510(k)
Top companies in DTZ
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 19, 1993 | K932252 | AFFINITY HOLLOW FIBER OXYGENATOR Avecor Cardiovascular, Inc. | DTZ |
| Nov 9, 1993 | K926467 | COBE CMS-FS MEMBRANE OXYGENATOR Cobe Cardiovascular, Inc. | DTZ |
| Sep 2, 1993 | K922799 | CAPIOX SX HOLLOW FIBER OXYGENATOR Terumo Medical Corp. | DTZ |
| Jun 22, 1993 | K926226 | INTERSEPT FILTERED CARDIOTOMY RESERVOIR Medtronic Vascular | DTZ |
| Jun 7, 1993 | K925076 | SARNS TURBO MEMBRANE OXYGENA. W/INT. CARDIOTOMY R. 3M Health Care, Sarns | DTZ |
| Jun 7, 1993 | K925075 | SARNS TURBO MEMBRANE OXYGENA. W/INT. RESERVOIR 3M Health Care, Sarns | DTZ |
| May 11, 1993 | K923272 | COBE CMS-HF HOLLOW FIBER MEMBRANE OXYGENATOR Cobe Laboratories, Inc. | DTZ |
| Feb 5, 1993 | K925626 | MAXIMA PLUS HOLLOW FIBER OXYGENATOR Medtronic Vascular | DTZ |
| Nov 30, 1992 | K922933 | SORIN MONOLYRH INTEGRATED MEMBRANE LUNG Sorin Biomedica, Fiat, USA, Inc. | DTZ |
| Sep 15, 1992 | K920889 | MINIMAX(R)/MAXIMA(R) HOLLOW FIBER OXYGENATORS Medtronic Vascular | DTZ |
| Dec 4, 1991 | K912082 | SAFE II Polystan A/S, DK | DTZ |
| Oct 23, 1991 | K912079 | SARNS SMOC MEMBRANE OXY W/INTEGRAT CARD RES,MODIFY 3M Health Care, Sarns | DTZ |
| Sep 25, 1991 | K912920 | SARNS SM03 MEMBRANE OXYGENATOR W/ INTEGRATED RESER 3M Health Care, Ltd. | DTZ |
| Sep 13, 1991 | K912655 | MINIMAX OXYGENATION SYSTEM Medtronic Vascular | DTZ |
| Aug 28, 1991 | K897068 | MEDTRONIC MINIMAX HOLLOW FIBER OXYGENATOR Medtronic Vascular | DTZ |
| Aug 20, 1991 | K912078 | SARNS SM03 MEMBRANE OXYGENATOR, MODIFICATION 3M Health Care, Sarns | DTZ |
| May 29, 1991 | K911227 | NEW STERILITY CHARACTER/SARNS OXYGENATOR PRODUCTS 3M Health Care, Sarns | DTZ |
| Apr 10, 1991 | K910107 | DURAFLO II HEPARIN OXYGENATOR MODEL UNIVOX GOLD Baxter Healthcare Corp | DTZ |
| Oct 19, 1990 | K903436 | SARNS MEMBRANE OXGENATOR PART NUMBER 9443 3M Health Care, Sarns | DTZ |
| Sep 5, 1990 | K901253 | (PBS) PORTABLE BYPASS SYSTEM, MODEL 1000 Bio Medicus, Inc. | DTZ |
| Jul 3, 1990 | K901624 | SHILEY PLEXUS INTEGRAL RESERVOIR HOLLOW FIBER OXY. Shiley, Inc. | DTZ |
| Jun 11, 1990 | K901250 | PLEXUS 2(TM) INFANT HOLLOW FIBER OXYGENATOR Shiley, Inc. | DTZ |
| Jun 11, 1990 | K901249 | PLEXUS 3.5(TM) PEDIATRIC HOLLOW FIBER OXYGENATOR Shiley, Inc. | DTZ |
| Feb 28, 1990 | K896978 | CLOSED CHEST SUPPORT CIRCUIT W/BIO-ACTIVE SURFACE Medtronic Vascular | DTZ |
| Feb 28, 1990 | K894826 | UNIVOX W/HOLDERS, MODELS UNIVOX-HL, HLB, HLF Bentley Laboratories, Inc. | DTZ |
| Feb 14, 1990 | K896671 | SARNS MEMBRANE OXYGENATOR W/INTEGRAL RESER. #9461 3M Company | DTZ |
| Feb 13, 1990 | K892664 | CARDIOPULMONARY SUPPORT (CPS) SYSTEM Bard Cardiosurgery Div | DTZ |
| Dec 22, 1989 | K893704 | SAFE-1 Polystan C/O Vitalcor, Inc., DK | DTZ |
| Dec 12, 1989 | K895632 | SARNS MEMBRANE OXYGENATOR W/INTEGRAL CADIO. 16380 3M Company | DTZ |
| Dec 12, 1989 | K893207 | CLOSED CHEST SUPPORT CIRCUIT Medtronic Blood Systems, Inc. | DTZ |
| Dec 4, 1989 | K895393 | SARNS INGANT MEMBRANE OXYGENATOR 3M Company | DTZ |
| Nov 1, 1989 | K894970 | WILLIAM HARVEY HF5000 MEMBRANE OXYGENATOR Minntech Corp. | DTZ |
| Nov 1, 1989 | K892641 | BARD WM HARVEY HF-5700 MEMB OXYGEN W/HARDSHELL RES Bard Cardiosurgery Div | DTZ |
| Oct 20, 1989 | K894630 | SHILEY PLEXUS(TM) ADULT HOLLOW FIBER OXYGENATOR Shiley, Inc. | DTZ |
| Sep 21, 1989 | K894103 | SCIMED ULTROX TRUE MEMBRANE OXYGEN SYST, ULTROX II Scimed Life Systems, Inc. | DTZ |
| May 31, 1989 | K891687 | EXTRACORPOREAL CIRCUIT WITH BIO-ACTIVE SURFACE Medtronic Blood Systems, Inc. | DTZ |
| May 19, 1989 | K891230 | MAXIMA* HOLLOW FIBER OXYGENATOR W/FILTERED RESERV. Medtronic Blood Systems, Inc. | DTZ |
| May 1, 1989 | K890808 | SARNS MEMBRANE OXYGENATOR W/INTEGRAL CARDIO RESERV 3M Company | DTZ |
| Sep 27, 1988 | K882892 | MEMBRANE OXYGENATOR Baxter Bentley Laboratories, Inc. | DTZ |
| Sep 26, 1988 | K883054 | SCIMED ULTROX TRUE MEMBRANE OXY. ULTROX I & II Scimed Life Systems, Inc. | DTZ |
| Sep 26, 1988 | K883053 | SCIMED MEMBRANE OXYGENATOR, MODEL 0600-2A Scimed Life Systems, Inc. | DTZ |
| Apr 1, 1988 | K880021 | COBE CML3 Cobe Laboratories, Inc. | DTZ |
| Feb 2, 1988 | K874841 | INTEGRATED MEMBRANE OXYGENATOR W/CARDIOTOMY FILTER Bentley Laboratories, Inc. | DTZ |
| Nov 6, 1987 | K873923 | INTEGRATED MEMBRANE OXYGENATOR W/CARDIOTOMY FILTER American Bentley | DTZ |
| Aug 28, 1987 | K872107 | WILLIAM HARVEY HF5000 MEMBRANE OXYGENATOR Minntech Corp. | DTZ |
| Aug 24, 1987 | K872133 | OXYGENATOR MODEL NO. BENTLEY 5 PLUS American Bentley | DTZ |
| Jan 2, 1987 | K864235 | BARD(R) WM HARVEY(R) BLOOD OXYGENATOR/MODEL H-1600 C.R. Bard, Inc. | DTZ |
| Nov 25, 1986 | K863476 | SCIMED MEMBRANE OXYGENATOR SYSTEM - ECMO Scimed Life Systems, Inc. | DTZ |
| Nov 18, 1986 | K863515 | MODIFIED SARNS OXYGENATOR SYSTEM 3M Health Care, Sarns | DTZ |
| Oct 20, 1986 | K863249 | OXYGENATOR MODEL NO. BENTLEY-10 PLUS American Bentley | DTZ |
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