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 |
|---|---|---|---|
| Jan 13, 2004 | K033323 | D 903 AVANT ADULT HOLLOW FIBER OXYGENATOR AND D 903 AVANT 2 PH.I.S.I.O. ADULT HOLLOW FIBER OXYGENATOR WITH COATING Dideco S.P.A. | DTZ |
| May 2, 2003 | K031223 | SYNTHESIS MIMESYS ADULT MEMBRANE OXYGENATOR Dideco S.P.A. | DTZ |
| Mar 31, 2003 | K023381 | VISION HOLLOW FIBER OXYGENATOR WITH GUARDIAN COATING Gish Biomedical, Inc. | DTZ |
| Feb 26, 2003 | K030264 | QUANDROX SAFELINE HOLLOW FIBER MEMBRANE OXYGENATOR, MODEL HMO 2030 Jostra AG, DE | DTZ |
| Oct 22, 2002 | K022450 | INTEGRATED UNIT: SYNTHESIS: ADULT MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDHSHELL VENOUS/CARDIOTOMY Dideco S.P.A. | DTZ |
| Sep 27, 2002 | K022115 | CAPIOX RX05 HOLLOW FIBER OXYGENATOR W/WITHOUT HARDSHELL RESERVOIR Terumo Corp. | DTZ |
| Aug 14, 2002 | K013038 | SAFE MAXI HOLLOW FIBER OXYGENATOR, MODEL 016010 Polystan A/S, DK | DTZ |
| Apr 4, 2002 | K020997 | APEX PH.I.S.I.O. ADULT HOLLOW FIBER MEMBRANE OXYGENATOR Dideco S.P.A. | DTZ |
| Feb 26, 2002 | K020351 | D 903 AVANT 2 PH.I.S.I.O. ADULT HOLLOW FIBER OXYGENATOR Dideco S.P.A. | DTZ |
| Jan 8, 2002 | K014080 | APEX ADULT HOLLOWE FIBER OXYGENATOR Dideco S.P.A. | DTZ |
| Dec 27, 2001 | K013915 | D902 PH.I.S.I.O OXYGENATOR; D920 PH.I.S.I.O RESERVOIR; DIDECO D736 PH.I.S.I.O FILTER Dideco S.P.A. | DTZ |
| Dec 11, 2001 | K010443 | CAPIOX SX10 HOLLOW FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR WITH X-COATING Terumo Cardiovascular Systems Corp. | DTZ |
| Nov 16, 2001 | K013480 | COBE SMARXT OPTIMIN SURFACE MODIFIED HOLLOW FIBER MEMBRANE OXYGENATOR Cobe Cardiovascular, Inc. | DTZ |
| Oct 4, 2001 | K004001 | MONOLYTH MIMESYS HOLLOW FIBER OXYGENATOR Dideco | DTZ |
| Sep 27, 2001 | K010478 | DIDECO D901 LILLIPUT HOLLOW FIBER OXYGENATOR WITH OR WITHOUT SOFT VENOUS RESERVOIR BAG, WITH BIOCOMPATABLE TREATMENT SUR Dideco | DTZ |
| Oct 13, 2000 | K980974 | SAFE MINI Polystan A/S, DK | DTZ |
| Jun 5, 2000 | K993772 | X-COATED CAPIOX SX18 AND SX25 HOLLOW FIBER OXYGENATOR WITH/ WITHOUT DETACHABLE HARDSHELL RESERVOIR Terumo Medical Corp. | DTZ |
| Apr 25, 2000 | K001021 | LILLIPUT PHOSPHOLYPIDIC INERT SURFACE IN OXYGENATION (PH.I.S.I.O.) INFANT HOLLOW FIBRE OXYGENATOR, MODEL D902 Dideco S.P.A. | DTZ |
| Apr 25, 2000 | K000255 | COBE SMARXT OPTIMA XP SURFACE MODIFIED HOLLOW FIBER MEMBRANE OXYGENATOR Cobe Cardiovascular, Inc. | DTZ |
| Feb 25, 2000 | K000430 | AFFINITY NT HOLLOW FIBER OXYGENATOR WITH PLASMA RESISTANT FIBER WITH CARMEDA BIOACTIVE SURFACE, MODEL CB511 Medtronic Vascular | DTZ |
| Feb 17, 2000 | K991737 | LILLIPUT PHOSPHOLYPIDIC INERT SURFACE IN OXYGENATION (PH.I.S.I.O.) INFANT/NEWBORN HOLLOW FIBER OXYGENATOR Dideco S.P.A. | DTZ |
| Nov 5, 1999 | K990103 | MONOLYTH C 600 AND 1200 HOLLOW FIBER MEMBRANE LUNG WITH INTEGRATED SOFTSHELL VENOUS RESERVOIR , CVR 600 AND 1200 SOFTSHE Sorin Biomedical, Inc. | DTZ |
| Oct 7, 1999 | K991452 | COBE OPTIMIN HOLLOW FIBER MEMBRANE OXYGENATOR Cobe Cardiovascular, Inc. | DTZ |
| Sep 20, 1999 | K992559 | HOLLOW FIBER MEMBRANE OYGENATOR QUADROX HMO 1010 Jostra Bentley | DTZ |
| Sep 15, 1999 | K992910 | AFFINITY NT HOLLOW FIBER OXYGENATOR WITH PLASMA RESISTANT FIBER WITH BALANCE BIOCOMPATIBLE SURFACE (MODEL 511B) Medtronic Vascular | DTZ |
| Mar 9, 1999 | K984271 | MODIFICATION OF MAXIMA FORTE' HOLLOW FIBER OXYGENATOR WITH BALANCE BIOCOMPATIBLE SURFACE WITH PLASMA RESISTENT FIBER (M0 Medtronic Vascular | DTZ |
| Jun 1, 1998 | K974812 | COBE(R) CML DUO(R) WITH SMART(TM) SURFACE MODIFIED MEMBRANCE OXYGENATOR Cobe Cardiovascular, Inc. | DTZ |
| Feb 18, 1998 | K973760 | AFFINITY HOLLOW FIBER OXYGENATOR WITH TRILLIUM BIOPASSIVE SURFACE Avecor Cardiovascular, Inc. | DTZ |
| Jan 27, 1998 | K974085 | COBE OXYGENATOR PRODUCTS Cobe Cardiovascular, Inc. | DTZ |
| Dec 8, 1997 | K963518 | COBE OPTIMA XP HOLLOW FIBER MEMBRANE OXYGENATOR Cobe Cardiovascular, Inc. | DTZ |
| Oct 8, 1997 | K971877 | LILLIPUT 2 INFANT HOLLOW FIBER OXYGENATOR Dideco S.P.A. | DTZ |
| Sep 29, 1997 | K964043 | COBE OPTIMA AND COBE CML DUO MEMBRANE OXYGENATORS Cobe Cardiovascular, Inc. | DTZ |
| Jul 7, 1997 | K961734 | CAPIOX 308 HOLLOW FIBER OXYGENATOR W/INTEGRATED HEAT EXCHANGE Terumo Medical Corp. | DTZ |
| May 6, 1997 | K970463 | CAPIOX E HOLLOW FIBER OXYGENATOR WITH INTEGRATED HEAT EXCHANGER/ARTERIAL RESERVOIR Terumo Medical Corp. | DTZ |
| Mar 6, 1997 | K964967 | BIOCOR 200 HIGH PERFORMANCEOXYGENATOR Minntech Corp. | DTZ |
| Feb 4, 1997 | K953976 | SAFE MICRO Polystan A/S, DK | DTZ |
| Dec 16, 1996 | K962641 | MAXIMA FORTE HOLLOW FIBER OXYGENATOR WITH PLASMA RESISTANT FIBER Medtronic Vascular | DTZ |
| Dec 5, 1996 | K961530 | GISH RELIANCE OXYGENATOR (MODEL HFO) Gish Biomedical, Inc. | DTZ |
| Oct 30, 1996 | K954850 | BARD WILLIAM HARVEY HF-6000 MEMBRANE OXYGENATOR C.R. Bard, Inc. | DTZ |
| Oct 16, 1996 | K960074 | CAPIOX SX10 HOLLOW FIBER OXYGENATOR WITH DETACHABLE HARDSHELL VENOUS RESERVOIR Terumo Medical Corp. | DTZ |
| Oct 7, 1996 | K962667 | CAPIOX SX25 HOLLOW FIBER OXYGENATOR WITH DETACHABLE HARDSHELL RESERVOIR Terumo Medical Corp. | DTZ |
| Oct 2, 1996 | K961000 | CAPIOX SX18 HOLLOW FIBER OXYGENATOR WITH AND WITHOUT DETACHABLE HARDSHELL RESERVOIR Terumo Medical Corp. | DTZ |
| Mar 15, 1996 | K953835 | LILLIPUT 1 NEW BORN HOLLOW FIBER OXYGENATOR Dideco S.R.L. | DTZ |
| Nov 2, 1995 | K951247 | SPIRALGOLD & SPIRALOXY HOLLOW FIBER OXYGENATORS Baxter Healthcare Corp | DTZ |
| Jun 21, 1995 | K941473 | MAXIMA PLUS HOLLOW FIBER OXYGENATOR Medtronic Vascular | DTZ |
| Aug 24, 1994 | K941653 | SARNS TURBO MEMBRANE OXYGENATOR MODIFICATION 3M Health Care, Sarns | DTZ |
| Aug 16, 1994 | K941225 | UNIVIX GOLD MEMBRANE OXYGENATION MODULE WITH DUROFLO II HEPARIN TREATMENT Baxter Healthcare Corp | DTZ |
| Jul 26, 1994 | K934292 | WILLIAM HARVEY HF5000 MEMBRANE OXYGENATOR Minntech Corp. | DTZ |
| May 27, 1994 | K931444 | PLEXUS 2 & 3.5 HOLLOW FIBER OXYGENATORS Sorin Biomedica, Fiat, USA, Inc. | DTZ |
| Feb 7, 1994 | K933586 | MINIMAX PLUS HOLLOW FIBER OXYGENATOR (WITH OR WITHOUT MEDTRONIC/CARMEDA BIOACTIVE SURFACE Medtronic Vascular | DTZ |
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