ClearanceBrief
Panels › Cardiovascular › Product code DTN · Class 2

Reservoir, Blood, Cardiopulmonary Bypass

Regulation 870.4400

1510(k)s in 12 months (169 all time)
0recalls in 12 months (47 all time)
46recalls that name a 510(k)
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Top companies in DTN

Decided510(k)Device and applicantCode
Jul 7, 2000K001822THE V-BAG
Circulatory Technology, Inc.
DTN
Jun 8, 2000K001602DIDECO LILLIPUT 1 TWIN RESERVOIR WITH PHOSPHORILCHOLINE INSERT SURFACE IN OXYGENATION (PH. I.S.I.O.)
Dideco S.P.A.
DTN
Mar 27, 2000K994389COBE HVR 2200 HARDSHELL VENOUS RESERVOIR, FILTERED
Cobe Cardiovascular, Inc.
DTN
Dec 3, 1999K993001COBE SMARXT HVR 4000 SURFACE MODIFIED HARDSHELL VENOUS RESERVOIR, FILTERED & NONFILTERED
Cobe Cardiovascular, Inc.
DTN
Nov 1, 1999K992599DIDECO ATS AUTOTRANSFUSION CARDIOTOMY RESERVOIR
Dideco S.P.A.
DTN
Sep 3, 1999K991973CAPIOX SX10 HARDSHELL RESEVOIR
Terumo Medical Corp.
DTN
Jun 29, 1999K984586FRESENIUS ATR40 AND ATR120 AUTOTRANSFUSION RESERVOIRS
Fresenius Hemotechnology, Inc.
DTN
May 25, 1999K990239COBE VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR
Cobe Cardiovascular, Inc.
DTN
Mar 24, 1999K982136JOSTRA VENOUS HARDSHELL CARDIOTOMIC RESERVOIR VHK 4200
Schiff & Co.
DTN
Jan 11, 1999K984456COBE HVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR
Cobe Cardiovascular, Inc.
DTN
Sep 10, 1998K982223CAPIOX SX HARDSHELL RESEVOIR
Terumo Medical Corp.
DTN
Aug 24, 1998K980786COBE CLOSED VENOUS RESERVOIR BAGS WITH SMARX T, MODELS VRB 1200 AND VRB 1800
Cobe Cardiovascular, Inc.
DTN
Aug 12, 1998K981284BETTER-BLADDER (BB)
Circulatory Technology, Inc.
DTN
Aug 5, 1998K981628BARD QUANTUM SVR MODEL NUMBER H-6440VR
C.R. Bard, Inc.
DTN
May 14, 1998K980935CAPIOX SX HARDSHELL RESERVOIR
Terumo Medical Corp.
DTN
Jan 22, 1998K974155BMR 4500 FILTERED VENOUS RESERVOIR AND BMR -4500 GOLD FILTERED VENOUS RESERVOIR WITH DURAFLO TREATMENT
Baxter Healthcare Corp
DTN
Oct 28, 1997K971013CHASE TEMPERATURE PROBE
Chase Medical, Inc.
DTN
Sep 10, 1997K972017BIOCOR SOFTSHELL VENOUS RESERVOIR (BIOCOR SVR)
Minntech Corp.
DTN
Sep 3, 1997K964908VRF40 VENOUS RESERVOIR WITH INTEGRAL CARDIOTOMY FILTER
Sorin Biomedical, Inc.
DTN
Aug 21, 1997K964907VENOMIDICARD PEDIATRIC VENOUS RESERVOIR WITH INTEGRALCARDIOTOMY FILTER/MIDICARD PEDIATRIC CARDIOTOMY RESERVOIR WITH FILT
Sorin Biomedical, Inc.
DTN
Jul 23, 1997K971669COBE HVR 4000 FILTERED AND NONFILTERED HARDSHELL VENOUS RESERVOIR
Cobe Cardiovascular, Inc.
DTN
Jul 11, 1997K971105MYOTHERM (TM) XP CARDIOPLEGIA DELIVERY SYSTEM
Avecor Cardiovascular, Inc.
DTN
Mar 10, 1997K964973GISH CAP VRF45 CARDIOTOMY/VENOUS RESERVOIR
Gish Biomedical, Inc.
DTN
Nov 1, 1996K961836MAXIMA FORTE HARDSHELL VENOUS RESERVOIR
Medtronic Vascular
DTN
Mar 7, 1996K953821BIOCOR 200 HARDSHELL VENOUS RESERVIOR
Minntech Corp.
DTN
Jan 11, 1996K955046SOFT VENOUS RESERVOIR
Gish Biomedical, Inc.
DTN
May 19, 1995K945065DIDECO FLEXIBLE RESERVOIR -- PRODUCT DESIGNATION 5063
Sorin Biomedical, Inc.
DTN
May 10, 1995K941215VENOMIDICARD INFANT/ PEDIATRIC VENOUS CARDIOTOMY RESERVOIR
Sorin Biomedical, Inc.
DTN
Jun 20, 1994K936003AFFINITY CVR
Avecor Cardiovascular, Inc.
DTN
May 10, 1994K935717AFFINITY VENOUS RESERVIOR BAG
Avecor Cardiovascular, Inc.
DTN
Apr 15, 1994K934847NGBCD & NGBCDP CARDIOPLEGIA DELIVERY SYSTEMS
Sorin Biomedical, Inc.
DTN
Apr 15, 1994K934763SORIN BLOOD CARDIOPLEGIA SYSTEM
Sorin Biomedical, Inc.
DTN
Mar 23, 1994K936183SORIN BCD ADVANCED PEDIATRIC BLOOD CARDIOPLEGIA SYSTEMS
Sorin Biomedical, Inc.
DTN
Mar 1, 1994K933713VENOUS RESERVIOR/CARDIOTOMY AUTOTRANSFUSION FILTER WITH DURAFLO II HEPARIN TREATMENT
Baxter Healthcare Corp
DTN
Feb 14, 1994K936286ATR-2900DF (WITH DEPTH FILTER)/CAP-35DF (WITH DEPTH FILTER)
Gish Biomedical, Inc.
DTN
Nov 2, 1993K933481SORIN MONOLYTH VENOUS RESERVOIR
Sorin Biomedical, Inc.
DTN
Jul 1, 1993K930154EL2-SERIES BLOOD COLLECTION REERVOIR
Electromedics, Inc.
DTN
Jun 22, 1993K930299BARD(R) BLOOD CARDIOPLEGIA HEAT EXCHANGER/TUBE SET
C.R. Bard, Inc.
DTN
May 13, 1993K920178CARDIOTOMY RESERVOIR W/20 MICRON FILITER
Lifestream Int'L, Inc.
DTN
Apr 20, 1993K925046PLEUR-EVAC CARDIOTOMY RESERVOIR
Deknatel, Inc., CR
DTN
Feb 19, 1993K926250ELECTROMEDICS EL-SERIES CARDIOTOMY RESERVOIR
Electromedics, Inc.
DTN
Dec 23, 1992K915573VENOUS RESERVOIR W/CARDIOTOMY FILTER
Baxter Healthcare Corp
DTN
Oct 19, 1992K920774MVR COLLAPSIBLE VENOUS RESERVOIR BAG
Medtronic Vascular
DTN
Oct 1, 1992K920312NEW COBE CARDIOPLEGIA SYSTEM
Cobe Cardiovascular, Inc.
DTN
Sep 3, 1992K915737AUTOTRANSFUSION BLOOD COLLECTION RESERVOIR
Electromedics, Inc.
DTN
Jan 21, 1992K913915BARD(R) WILLIAM HARVEY(R) MACRO FILT CARDIO RESERV
Bard Cardiosurgery Div
DTN
Jan 17, 1992K913956BLOOD CARDIOPLEGIA HEAT EXCHANGER, MODEL #HE-30
Bentley Laboratories, Inc.
DTN
Nov 15, 1991K913692VENOUS RESERVOIR BAG MODEL NO. BMR-250(TM)
Bentley Laboratories, Inc.
DTN
Aug 12, 1991K911790MINIMAX (TM) COLLAPSIBLE VENOUS RESERVOIR BAG
Medtronic Vascular
DTN
Aug 9, 1991K911876SHILEY PLEXUS(R) VENOUS RESERVOIR, PVR1200
Shiley, Inc.
DTN

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