Company ยท US
Cobe Cardiovascular, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1992 to 2005. Name variants (Inc, Corp, punctuation) are merged.
43510(k) clearances (0 in 12 months)
21recalls (0 in 12 months)
18recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| CAC | Apparatus, Autotransfusion | 17 |
| DTZ | Oxygenator, Cardiopulmonary Bypass | 16 |
| DTN | Reservoir, Blood, Cardiopulmonary Bypass | 11 |
| DTM | Filter, Blood, Cardiopulmonary Bypass, Arterial Line | 4 |
| DTR | Heat-Exchanger, Cardiopulmonary Bypass | 3 |
| DTP | Defoamer, Cardiopulmonary Bypass | 2 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 2 |
| KFM | Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type | 2 |
| DQO | Catheter, Intravascular, Diagnostic | 1 |
| DRS | Transducer, Blood-Pressure, Extravascular | 1 |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 1 |
| DWB | Pump, Blood, Cardiopulmonary Bypass, Roller Type | 1 |
| DWE | Tubing, Pump, Cardiopulmonary Bypass | 1 |
| JQC | Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | 1 |
| MJJ | Cpb Check Valve, Retrograde Flow, In-Line | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 8, 2005 | K050111 | SMARXT BMR 1900 CLOSED VENOUS RESERVOIR BAG Cobe Cardiovascular, Inc. | DTN |
| Nov 19, 2004 | K042473 | COBE ANGEL WHOLE BLOOD SEPARATION SYSTEM Cobe Cardiovascular, Inc. | JQC |
| Feb 26, 2004 | K040184 | DIDECO MICRO 40 PH.I.S.I.O. ADULT ARTERIAL FILTER Cobe Cardiovascular, Inc. | DTM |
| Dec 11, 2003 | K033641 | SMARXT VVR4000I PLUS FILTERED HARDSHELL VENOUS RESERVOIR, MODEL 439914800 Cobe Cardiovascular, Inc. | DTN |
| Mar 6, 2003 | K030462 | COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC, MODEL 050300700 Cobe Cardiovascular, Inc. | KFM |
| Jul 2, 2002 | K021830 | SORIN BIOMEDICA SMARXT BCD VANGUARD SURFACE MODIFIED CARDIOPLEGIA SYSTEM Cobe Cardiovascular, Inc. | DTR |
| Feb 12, 2002 | K011835 | COBE REVOLUTION Cobe Cardiovascular, Inc. | KFM |
| Nov 16, 2001 | K013480 | COBE SMARXT OPTIMIN SURFACE MODIFIED HOLLOW FIBER MEMBRANE OXYGENATOR Cobe Cardiovascular, Inc. | DTZ |
| Nov 15, 2001 | K012763 | SORIN BIOMEDICA SMART BCD VANGUARD,SURFACE MODIFIED BLOOD CARDIOPLEGIA SYSTEM Cobe Cardiovascular, Inc. | DRT |
| Oct 26, 2001 | K001509 | STOCKERT V172 SERIES VENOUS FEMORAL CANNULAE Cobe Cardiovascular, Inc. | DWF |
| Sep 17, 2001 | K012898 | MODIFICATION TO: CSC14 BLOOD CARDIOPLEGIA SYSTEM Cobe Cardiovascular, Inc. | DTR |
| Apr 26, 2001 | K004046 | COBE VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR, COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR Cobe Cardiovascular, Inc. | DTP |
| Nov 30, 2000 | K002493 | DIDECO MICRO 40 PH.I.S.I.O (PHOSPHORYLCHOLINE INSERT SURFACE IN OXGENATION) NEWBORN/INFANT ARTERIAL FILTER Cobe Cardiovascular, Inc. | DTM |
| Sep 13, 2000 | K002591 | COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR Cobe Cardiovascular, Inc. | DTP |
| Jun 14, 2000 | K994209 | STOCKERT V142 SERIES VENOUS CANNULAE WITH LIGHTHOUSE TIP Cobe Cardiovascular, Inc. | DWF |
| Apr 25, 2000 | K000255 | COBE SMARXT OPTIMA XP SURFACE MODIFIED HOLLOW FIBER MEMBRANE OXYGENATOR Cobe Cardiovascular, Inc. | DTZ |
| Mar 27, 2000 | K994389 | COBE HVR 2200 HARDSHELL VENOUS RESERVOIR, FILTERED Cobe Cardiovascular, Inc. | DTN |
| Dec 3, 1999 | K993001 | COBE SMARXT HVR 4000 SURFACE MODIFIED HARDSHELL VENOUS RESERVOIR, FILTERED & NONFILTERED Cobe Cardiovascular, Inc. | DTN |
| Oct 7, 1999 | K991452 | COBE OPTIMIN HOLLOW FIBER MEMBRANE OXYGENATOR Cobe Cardiovascular, Inc. | DTZ |
| Sep 9, 1999 | K991986 | COBE BRAT 2 AUTOLOGOUS BLOOD SALVAGE SYSTEM WITH THE CRIT-LINE HEMATOCRIT SAMPLING SYSTEM OPTION Cobe Cardiovascular, Inc. | CAC |
| May 25, 1999 | K990239 | COBE VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR Cobe Cardiovascular, Inc. | DTN |
| Jan 11, 1999 | K984456 | COBE HVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR Cobe Cardiovascular, Inc. | DTN |
| Oct 26, 1998 | K981613 | COBE SMARXT TUBING AND CONNECTORS Cobe Cardiovascular, Inc. | DWE |
| Oct 7, 1998 | K982406 | COBE VACUUM RELIEF CHECK VALVE Cobe Cardiovascular, Inc. | MJJ |
| Sep 10, 1998 | K982254 | COBE SENTRY SMARXT 43 MICRON ARTERIAL FILTER WITH PRIMEGARD Cobe Cardiovascular, Inc. | DTM |
| Aug 24, 1998 | K980786 | COBE CLOSED VENOUS RESERVOIR BAGS WITH SMARX T, MODELS VRB 1200 AND VRB 1800 Cobe Cardiovascular, Inc. | DTN |
| Jun 1, 1998 | K974812 | COBE(R) CML DUO(R) WITH SMART(TM) SURFACE MODIFIED MEMBRANCE OXYGENATOR Cobe Cardiovascular, Inc. | DTZ |
| Mar 31, 1998 | K974897 | COBE BRAT 2 SYSTEM WITH MODIFIED STANDARD VOLUME PROCESSING SET Cobe Cardiovascular, Inc. | CAC |
| 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 |
| Nov 3, 1997 | K973627 | STANDARD VOLUME PROCESSING SET FOR THE COBE BRAT 2 AUTOLOGOUS BLOOD SALVAGE SYSTEM Cobe Cardiovascular, Inc. | CAC |
| Sep 29, 1997 | K964043 | COBE OPTIMA AND COBE CML DUO MEMBRANE OXYGENATORS Cobe Cardiovascular, Inc. | DTZ |
| Jul 23, 1997 | K971669 | COBE HVR 4000 FILTERED AND NONFILTERED HARDSHELL VENOUS RESERVOIR Cobe Cardiovascular, Inc. | DTN |
| Jul 14, 1997 | K960974 | COBE CENTURY PERFUSION PUMP Cobe Cardiovascular, Inc. | DWB |
| Jan 28, 1997 | K962689 | COBE BRAT 2 AUTOLOGOUS BLOOD SALVAGE SYSTEM WITH MODIFIED PLASMA RECOVERY PROGRAM (PRP) Cobe Cardiovascular, Inc. | CAC |
| Apr 28, 1995 | K944267 | HEAT EXCHANGER MODIFICATION FOR DUO AND OPTIMA Cobe Cardiovascular, Inc. | DTR |
| Jun 10, 1994 | K933960 | PLASMA RECOVERY PROGRAM FOR THE COBE BRAT 2 AUTOLOGOUS BLOOD SALVAGE SYSTEM Cobe Cardiovascular, Inc. | CAC |
| Dec 29, 1993 | K933625 | BRAT 2 AUTOLOGUS BLOOD SALVAGE SYSTEM Cobe Cardiovascular, Inc. | CAC |
| Nov 9, 1993 | K926467 | COBE CMS-FS MEMBRANE OXYGENATOR Cobe Cardiovascular, Inc. | DTZ |
| Jan 5, 1993 | K921343 | COBE PATIENT MONITORING PRODUCTS Cobe Cardiovascular, Inc. | DRS |
| Dec 3, 1992 | K922484 | COBE SAMPLING SITE Cobe Cardiovascular, Inc. | DQO |
| Oct 1, 1992 | K920312 | NEW COBE CARDIOPLEGIA SYSTEM Cobe Cardiovascular, Inc. | DTN |
| Jan 27, 1992 | K913773 | COBE BRAT SYSTEMS WITHOUT REINFUSION PROTECTION Cobe Cardiovascular, Inc. | CAC |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 9, 2006 | Cobe Cardiovascular, Inc Cobe STAT PAC Autotransfusion Set (made with Electa Wash Set), Cobe Product Codes: ASCBFE22, ASCBE22, AS9E55, AS9E22, AS9E12, AS4E55, AS4E22, AS4E17. Cobe Cardiovascular Inc. Terminated |
CAC | K020647 |
| Sep 9, 2006 | Cobe Cardiovascular, Inc Cobe STAT PAC, Autotransfusion Set (Made with Compact Wash Sets), Cobe Product Codes: AS4C12, AS4C22, ASCBC12C, ASCBC22C, ASCBFC22C. Cobe Cardiovascular Inc. Terminated |
CAC | K982650 |
| Sep 9, 2006 | Cobe Cardiovascular, Inc dideco Preassembled Surgical Wash Set, Electa Essential , Cobe part numbers WS55E, WS125E, WS175E, WS225E, Cobe Cardiovascular, Inc. Terminated |
CAC | K020647 |
| Sep 9, 2006 | Cobe Cardiovascular, Inc dideco Preassembled Surgical Wash Set, Compact , Cobe part numbers WS55C, WS125C, WS225C, Cobe Cardiovascular, Inc. Terminated |
CAC | K982650 |
| Aug 24, 2006 | Cobe Cardiovascular, Inc Cobe CML Duo Flat Sheet Membrane Oxygenator, Non-sterile, Catalog Number: 436122974, COBE Cardiovascular, Inc..-(shipped international only for use in Heart/Lung Packs) Terminated |
DTZ | None listed |
| Aug 24, 2006 | Cobe Cardiovascular, Inc Cobe Optima XP Hollow Fiber Membrane Oxygenator, Non-Sterile, Catalog Number 436422974, COBE Cardiovascular, Inc.. (shipped International only for use in Heart/Lung packs) Terminated |
DTZ | None listed |
| Aug 24, 2006 | Cobe Cardiovascular, Inc Cobe Optimin Hollow Fiber Sealed System, Sterile, (Custom Heart / Lung Pack), Catalog Numbers: 067350004, 067734001, 067736002. COBE Cardiovascular, Inc.. Terminated |
DTZ | K013480 K991452 |
| Aug 24, 2006 | Cobe Cardiovascular, Inc Cobe CML Duo Flat Sheet Membrane Oxygenator, sterile, (Custom Heart/Lung Packs), Catalog numbers: 067100001, 078002103, 078005802, 078159025, 078201013, 078212009, 078310006, 078332022, 078348014, 07 Terminated |
DTZ | K000255 K963518 |
| Aug 24, 2006 | Cobe Cardiovascular, Inc Cobe Optima XP Hollow Fiber Membrane Oxygenator, Sterile, (Custom Heart/Lung Packs), Catalog Numbers: 028901008, 032794001, 067129002, 067149006, 067174002, 067188002, 067212004, 067221009, 067236004, Terminated |
DTZ | K926467 K974812 |
| Aug 24, 2006 | Cobe Cardiovascular, Inc Cobe Optimin Hollow Fiber Sealed System, Oxygenator/Reservoir, Sterile, (Standalone systems), Catalog numbers:050125400, 050502000. COBE Cardiovascular, Inc.. Terminated |
DTZ | K013480 K991452 |
| Aug 24, 2006 | Cobe Cardiovascular, Inc Cobe CML Duo Flat Sheet Membrane Oxygenator/Reservoir, sterile, (Standalone systems). Catalog Numbers: 050226400, 050422400. COBE Cardiovascular, Inc.. Terminated |
DTZ | K000255 K963518 |
| Aug 24, 2006 | Cobe Cardiovascular, Inc Cobe Optima XP Hollow Fiber Membrane Oxygenator/Reservoir, Sterile, (Standalone Systems) Catalog Numbers 050255500, 050316400, 050412400, 050500000. COBE Cardiovascular, Inc.. Terminated |
DTZ | K926467 K974812 |
| Dec 2, 2005 | Cobe Cardiovascular, Inc Custom heart lung perfusion packs Terminated |
DTM | None listed |
| Aug 3, 2005 | Cobe Cardiovascular, Inc ASY, Brat 2 Procedure Set Terminated |
CAC | K933625 |
| Aug 3, 2005 | Cobe Cardiovascular, Inc ASY Brat 2 Procedure Set Terminated |
CAC | K933625 |
| Aug 3, 2005 | Cobe Cardiovascular, Inc ASY, Brat Pack Procedure Set Terminated |
CAC | K933625 |
| Aug 3, 2005 | Cobe Cardiovascular, Inc ASY Brat 2 Procedure Set Terminated |
CAC | K933625 |
| Aug 3, 2005 | Cobe Cardiovascular, Inc ASY, Brat 2 Pack Procedure Set Terminated |
CAC | K933625 |
| Aug 3, 2005 | Cobe Cardiovascular, Inc ASY Brat 2 Procedure Set, for blood recovery & autotransfusion. Terminated |
CAC | K933625 |
| Jul 20, 2004 | Cobe Cardiovascular, Inc Cardioplegia Pack BCD Vanguard Ratio 4:1 with Shunt Terminated |
DTN | K934847 |
| Jul 2, 2003 | Cobe Cardiovascular, Inc Cobe Cardiovascular BCD Vanguard Cardioplegia Delivery System, 8:1 with Shunt. Terminated |
DTN | K934847 |