Anesthesiology
Review Panel
- CardiovascularReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart D—Cardiovascular Prosthetic DevicesCFR Sub-Part
- Subpart E—Cardiovascular Surgical DevicesCFR Sub-Part
- BYSOxygenator, Long Term Support Greater Than 6 Hours2Product Code
- DRYMonitor, Blood-Gas, On-Line, Cardiopulmonary Bypass2Product Code
- DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass2Product Code
- DTMFilter, Blood, Cardiopulmonary Bypass, Arterial Line2Product Code
- DTNReservoir, Blood, Cardiopulmonary Bypass2Product Code
- K241206Quantum Perfusion Hybrid System2Cleared 510(K)
- K241053MVR™ Venous Reservoir Bag 800 mL; MVR™ Venous Reservoir Bag 1600 mL; MVR™ Venous Reservoir Bag with Cortiva™ BioActive Surface 800 mL; MVR™ Venous Reservoir Bag with Cortiva™ BioActive Surface 1600 mL2Cleared 510(K)
- K223361BMR 1900 PHISIO2Cleared 510(K)
- K170583Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive Surface2Cleared 510(K)
- K161733INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F C2Cleared 510(K)
- K153143Capiox Advance Hardshell Reservoir2Cleared 510(K)
- K151110Intersept Filtered Cardiotomy Reservoir2Cleared 510(K)
- K141432NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVIOR, PEDIATRIC VENOUS HARDSHELL CARDIOTOMY RESERVIOR, NEONATAL VENOUS HARDHSH2Cleared 510(K)
- K141233AFFINITY PIXIE OXYGENATION SYSTEM WITH; CARMEDA BIOACTIVE SURFACE, BALANCE BIOSUFACE2Cleared 510(K)
- K140321INITARY BETTER BLADDER-PEDIATRIC2Cleared 510(K)
- K132166VENOUS HARDSHELL CARDIOTOMY RESERVOIR; NON-COATED, NON-TIGHT/ VACUUM-TIGHT/ WITH SOFTLINE COATING, VACUUM-TIGHT2Cleared 510(K)
- K132972AFFINITY FUSION CARDIOTOMY/VENOUS RESERVOIR WITH BALANCE BIOSURFACE2Cleared 510(K)
- K131103XRES BLOOD COLLECTION RESERVOIR XRES 120MICROMETER BLOOD COLLECTION RESERVOIR2Cleared 510(K)
- K122914AFFINITY FUSION CARDIOTOMY/VENOUS RESERVIOR WITH BALANCE BIOSURFACE MODEL BB841, AFFINITY FUSION CARDIOTOMY/ VENOUS RESE2Cleared 510(K)
- K112771BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG2Cleared 510(K)
- K102919NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVOIR, PEDIATRIC VENOUS HARDSHELL CARSIOTOMY RESERVOIR, NEONATAL VENOUS HARDSHE2Cleared 510(K)
- K100507XRES BLOOD COLLECTION RESERVOIR2Cleared 510(K)
- K090690VENOUS SOFTBAG RESERVOIRS WITH SOFTLINE COATING2Cleared 510(K)
- K090534VENOUS HARDSHELL CARDIOTOMY RESERVIORS2Cleared 510(K)
- K092315SORIN VVR 4000I AND 4000I SMARXT FILTERED HARDSHELL VENOUS RESERVOIR2Cleared 510(K)
- K091062MEDOS HILITE INFANT RESERVOIR, MODEL MVC 07302Cleared 510(K)
- K083131MEDOS HILITE RESERVOIR, MODEL: 40302Cleared 510(K)
- K082082GISH SVR SOFT VENOUS RESERVOIRS WITH HA COATING2Cleared 510(K)
- K081947GISH CAPVRF44 HARDSHELL VENOUS RESERVOIR WITH HA COATING2Cleared 510(K)
- K070605JOSTRA VENOUS SOFTBAG RESERVOIRS WITH AND WITHOUT SAFELINE COATING2Cleared 510(K)
- K0726973T BLOOD COLLECTION CARDIOTOMY RESERVOIRS AND ACCESSORIES2Cleared 510(K)
- K070839MODIFICATION TO CAPIOX FLEXIBLE VENOUS RESERVOIR2Cleared 510(K)
- K061743VENOUS HARDSHELL CARDIOTOMY RESERVOIR W/SAFELINE COATING, MODEL BSQ-VHK 2000;VACUUM TIGHT, MODEL BSQ-VHK 20012Cleared 510(K)
- K061527CARD 43 CARDIOTOMY RESERVOIR WITH PHOSPHORYLCHOLINE COATING2Cleared 510(K)
- K051606GISH ATR2900 AND CAP35 SERIES RESERVOIRS WITH GBS COATING2Cleared 510(K)
- K050195V-BAG WITH GBS COATING2Cleared 510(K)
- K050111SMARXT BMR 1900 CLOSED VENOUS RESERVOIR BAG2Cleared 510(K)
- K040023CAPIOX FLEXIBLE VENOUS RESERVOIR2Cleared 510(K)
- K033800CAPIOX CARDIOTOMY RESERVOIR2Cleared 510(K)
- K033714MVR 1200 PC: SORIN MONOLYTH VENOUS RESERVOIR 1200 PC WITH PHOSPHORYLCHOLINE COATING2Cleared 510(K)
- K033641SMARXT VVR4000I PLUS FILTERED HARDSHELL VENOUS RESERVOIR, MODEL 4399148002Cleared 510(K)
- K031700MEDTRONIC RESTING HEART SYSTEM, MODEL AAR1000 AND 7112Cleared 510(K)
- K031150HEMOBAG, MODEL HBBSD20002Cleared 510(K)
- K030726GISH CAPVRF44 HARDSHELL VENOUS RESERVOIR WITH GBS COATING2Cleared 510(K)
- K030449MODIFICATION TO CAPIOX SX10 HARDSHELL RESERVOIR2Cleared 510(K)
- K024065SOFT VENOUS RESERVOIR (SVRXX) WITH GBS COATING2Cleared 510(K)
- K022281SAFE MAXI VENOUS/CARDIOTOMY RESERVIOR, MODEL 0160452Cleared 510(K)
- K021287TRILLIUM AFFINITY NT CARDIOTOMY VENOUS RESERVOIR, MODELS 540T, 541TT2Cleared 510(K)
- K013526CAPIOX RX HARDSHELL RESERVOIR2Cleared 510(K)
- K012942THE V BAG, CATALOG NUMBER VB1800; VAC-BOX FOR VACUUM ASSISTED VENOUS DRAINAGE, CATALOG NUMBER VACBOX15002Cleared 510(K)
- K003551VENOUS HARDSHELL CARDIOTOMY RESEVOIR, MODEL VHK 42012Cleared 510(K)
- K011864TRILLIUM MYOTHERM XP CARDIOPLEGIA DELIVERY SYSTEM, MODELS 41, 41-B2Cleared 510(K)
- K002496MODEL 4815 ADAPTER2Cleared 510(K)
- K002238CAPIOX SX HARDSHELL RESERVOIR WITH X-COATING2Cleared 510(K)
- K001822THE V-BAG2Cleared 510(K)
- K001602DIDECO LILLIPUT 1 TWIN RESERVOIR WITH PHOSPHORILCHOLINE INSERT SURFACE IN OXYGENATION (PH. I.S.I.O.)2Cleared 510(K)
- K994389COBE HVR 2200 HARDSHELL VENOUS RESERVOIR, FILTERED2Cleared 510(K)
- K993001COBE SMARXT HVR 4000 SURFACE MODIFIED HARDSHELL VENOUS RESERVOIR, FILTERED & NONFILTERED2Cleared 510(K)
- K992599DIDECO ATS AUTOTRANSFUSION CARDIOTOMY RESERVOIR2Cleared 510(K)
- K991973CAPIOX SX10 HARDSHELL RESEVOIR2Cleared 510(K)
- K984586FRESENIUS ATR40 AND ATR120 AUTOTRANSFUSION RESERVOIRS2Cleared 510(K)
- K990239COBE VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR2Cleared 510(K)
- K982136JOSTRA VENOUS HARDSHELL CARDIOTOMIC RESERVOIR VHK 42002Cleared 510(K)
- K984456COBE HVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR2Cleared 510(K)
- K982223CAPIOX SX HARDSHELL RESEVOIR2Cleared 510(K)
- K980786COBE CLOSED VENOUS RESERVOIR BAGS WITH SMARX T, MODELS VRB 1200 AND VRB 18002Cleared 510(K)
- K981284BETTER-BLADDER (BB)2Cleared 510(K)
- K981628BARD QUANTUM SVR MODEL NUMBER H-6440VR2Cleared 510(K)
- K980935CAPIOX SX HARDSHELL RESERVOIR2Cleared 510(K)
- K974155BMR 4500 FILTERED VENOUS RESERVOIR AND BMR -4500 GOLD FILTERED VENOUS RESERVOIR WITH DURAFLO TREATMENT2Cleared 510(K)
- K971013CHASE TEMPERATURE PROBE2Cleared 510(K)
- K972017BIOCOR SOFTSHELL VENOUS RESERVOIR (BIOCOR SVR)2Cleared 510(K)
- K964908VRF40 VENOUS RESERVOIR WITH INTEGRAL CARDIOTOMY FILTER2Cleared 510(K)
- K964907VENOMIDICARD PEDIATRIC VENOUS RESERVOIR WITH INTEGRALCARDIOTOMY FILTER/MIDICARD PEDIATRIC CARDIOTOMY RESERVOIR WITH FILT2Cleared 510(K)
- K971669COBE HVR 4000 FILTERED AND NONFILTERED HARDSHELL VENOUS RESERVOIR2Cleared 510(K)
- K971105MYOTHERM (TM) XP CARDIOPLEGIA DELIVERY SYSTEM2Cleared 510(K)
- K964973GISH CAP VRF45 CARDIOTOMY/VENOUS RESERVOIR2Cleared 510(K)
- K961836MAXIMA FORTE HARDSHELL VENOUS RESERVOIR2Cleared 510(K)
- K953821BIOCOR 200 HARDSHELL VENOUS RESERVIOR2Cleared 510(K)
- K955046SOFT VENOUS RESERVOIR2Cleared 510(K)
- K945065DIDECO FLEXIBLE RESERVOIR -- PRODUCT DESIGNATION 50632Cleared 510(K)
- K941215VENOMIDICARD INFANT/ PEDIATRIC VENOUS CARDIOTOMY RESERVOIR2Cleared 510(K)
- K936003AFFINITY CVR2Cleared 510(K)
- K935717AFFINITY VENOUS RESERVIOR BAG2Cleared 510(K)
- K934847NGBCD & NGBCDP CARDIOPLEGIA DELIVERY SYSTEMS2Cleared 510(K)
- K934763SORIN BLOOD CARDIOPLEGIA SYSTEM2Cleared 510(K)
- K936183SORIN BCD ADVANCED PEDIATRIC BLOOD CARDIOPLEGIA SYSTEMS2Cleared 510(K)
- K933713VENOUS RESERVIOR/CARDIOTOMY AUTOTRANSFUSION FILTER WITH DURAFLO II HEPARIN TREATMENT2Cleared 510(K)
- K936286ATR-2900DF (WITH DEPTH FILTER)/CAP-35DF (WITH DEPTH FILTER)2Cleared 510(K)
- K933481SORIN MONOLYTH VENOUS RESERVOIR2Cleared 510(K)
- K930154EL2-SERIES BLOOD COLLECTION REERVOIR2Cleared 510(K)
- K930299BARD(R) BLOOD CARDIOPLEGIA HEAT EXCHANGER/TUBE SET2Cleared 510(K)
- K920178CARDIOTOMY RESERVOIR W/20 MICRON FILITER2Cleared 510(K)
- K925046PLEUR-EVAC CARDIOTOMY RESERVOIR2Cleared 510(K)
- K926250ELECTROMEDICS EL-SERIES CARDIOTOMY RESERVOIR2Cleared 510(K)
- K915573VENOUS RESERVOIR W/CARDIOTOMY FILTER2Cleared 510(K)
- K920774MVR COLLAPSIBLE VENOUS RESERVOIR BAG2Cleared 510(K)
- K920312NEW COBE CARDIOPLEGIA SYSTEM2Cleared 510(K)
- K915737AUTOTRANSFUSION BLOOD COLLECTION RESERVOIR2Cleared 510(K)
- K913915BARD(R) WILLIAM HARVEY(R) MACRO FILT CARDIO RESERV2Cleared 510(K)
- K913956BLOOD CARDIOPLEGIA HEAT EXCHANGER, MODEL #HE-302Cleared 510(K)
- K913692VENOUS RESERVOIR BAG MODEL NO. BMR-250(TM)2Cleared 510(K)
- K911790MINIMAX (TM) COLLAPSIBLE VENOUS RESERVOIR BAG2Cleared 510(K)
- K911876SHILEY PLEXUS(R) VENOUS RESERVOIR, PVR12002Cleared 510(K)
- K905818VACUUM-ASSISTED BLOOD COLLECTION SYSTEM2Cleared 510(K)
- K903632INTERSEPT 1375 VENOUS RESERVOIR2Cleared 510(K)
- K902631COBE ICU CONVERSION KIT2Cleared 510(K)
- K904040SOFTSHELL VENOUS RESERVOIR2Cleared 510(K)
- K894664CAPIOX HARDSHELL VENOUS RESERVOIR2Cleared 510(K)
- K895356UNIVOX-IC2Cleared 510(K)
- K893711DIDECO-SHILEY AUTOTRANSFUSION CARDIOTOMY RESERVOIR2Cleared 510(K)
- K896414VENOUS RESERVOIR BAG MODEL NO. BMR-800 W/HEPARIN2Cleared 510(K)
- K893705SAFE-1 VENOUS RESERVOIR2Cleared 510(K)
- K895076CMS VRB-12002Cleared 510(K)
- K890077TRAUMAFUSE RAPID INFUSION DEVICE2Cleared 510(K)
- K884872DIDECO-SHILEY AUTOTRANSFUSION CARDIOTOMY RESERVOIR2Cleared 510(K)
- K882414BLOOD RESERVOIR, CARDIOPULMONARY BYPASS2Cleared 510(K)
- K883923CARDIOTOMY/VENOUS RESERVOIR NO.: CVR SERIES2Cleared 510(K)
- K882380SCIMED MODEL SM-C/VR CARDIOTOMY/VENOUS RESERVOIR2Cleared 510(K)
- K883345SARNS INFANT VENOUS RESERVOIR MODEL #163872Cleared 510(K)
- K882720SCIMED R30 SILICONE ASSIST RESERVOIR2Cleared 510(K)
- K873423MAXIMA* COLLAPSIBLE VENOUS RESERVOIR BAG & HOLDER2Cleared 510(K)
- K872719EXPANDED USE OF HARDSHELL VENOUS RESERV. W/FILTER2Cleared 510(K)
- K872722EXPANDED USE FOR SHILEY 3L CARDF PLUS2Cleared 510(K)
- K872721EXPANDED USE FOR SHILEY 3L CARDIOTOMY RESERVOIR2Cleared 510(K)
- K872720SHILEY PTS CHEST DRAINAGE AUTOTRANSFUSION SET2Cleared 510(K)
- K872378WILLIAM HARVEY HARDSHELL VENOUS RESERVOIR2Cleared 510(K)
- K871775STAT-VAC CHEST DRAINAGE SYSTEM2Cleared 510(K)
- K870829SARNS MEMBRANE OXYGENATOR W/INTEGRAL RESERVOIR2Cleared 510(K)
- K864895INTERSEPT* CARDIOTOMY RESERVOIR WITH FILTER2Cleared 510(K)
- K862920BARD WILLIAM HARVEY CARDIOTOMY RESERVOIR2Cleared 510(K)
- K862357MODIFIED CARDIOTOMY RESERVOIR 5M14702Cleared 510(K)
- K854841SHILEY VENOUS RESERVOIR2Cleared 510(K)
- K852382CARDIOTOMY/MEDIASTINAL AUTOTRANSFUSION RESERVOIR2Cleared 510(K)
- K851401VENUOS RESERVOIR BAG BMR-19002Cleared 510(K)
- K851376VENOUS RESERVOIR BAG BMR-16002Cleared 510(K)
- K842391ACR 2500 CARDIOTOMY RESERVOIR FILTER2Cleared 510(K)
- K843888CARDIOTOMY RESERVOIR BRS-XXX SERIES &2Cleared 510(K)
- K843595CARDIOTOMY RESERVOIR W/FILTER2Cleared 510(K)
- K844367CARDIOTOMY RESERVOIR W/FILTER BCR-25002Cleared 510(K)
- K844366CARDIOTOMY RESERVOIR BCR-20002Cleared 510(K)
- K844229VENOUS RESERVOIR VRS-XXX SERIES; HOLDER VRS-HXX2Cleared 510(K)
- K843232SHILEY HARDSHELL VENOUS RESERVOIR W/INT2Cleared 510(K)
- K842620CARDIOTOMY RESERVOIR W/FILTER BCR-35002Cleared 510(K)
- K842337SHILEY VENOUS RESERVOIR2Cleared 510(K)
- K842711SHILEY CARDIOTOMY RESERVOIR W/FILTER2Cleared 510(K)
- K841938CARDIOPLEGIA RESERVOIR CAS-20002Cleared 510(K)
- K841031OXYHI CRYSTALLOID CARDIOPLEGIA SOLUT2Cleared 510(K)
- K841175WILLIAM HARVEY H-4720 NON-FILTERED CAR2Cleared 510(K)
- K841079WILLIAM HARVEY H-4700 FILTER/CARDIO2Cleared 510(K)
- K834373CARDIOTOMY RESERVORS BCR-3000/3500-Q-1202Cleared 510(K)
- K832802USE OF TWEEN 80 AS A WETTING AGENT ON2Cleared 510(K)
- K832671CARDIOTOMY RESERVOIR-FILTER 050-108-0502Cleared 510(K)
- K833479WILLIAM HARVEY H-71-5-F CARDIOTOMY2Cleared 510(K)
- K832924VENOUS RESERVOIR2Cleared 510(K)
- K831966CARDIOPLEGIA RESERVOIR-#5009262Cleared 510(K)
- K823272VENOUS RESERVOIR BAG #BMR-14002Cleared 510(K)
- K823205EXV VENOUS RESERVOIR BAG & HOLDER2Cleared 510(K)
- K820727CARDIOTOMY RESERVOIRS2Cleared 510(K)
- K821442WILLIAM HARVEY FLEX. VENOUS RESERVOIR2Cleared 510(K)
- K813268SC-2500F CARDIOTOMY RESERVIOR2Cleared 510(K)
- K812455SUCKER CARDIOTOMY RETURN, C.P. BYPASS2Cleared 510(K)
- K812008CORDIOTOMY RESERVOIR2Cleared 510(K)
- K812009CARDIOTOMY RESERVOIR W/FILTER#BCR-35002Cleared 510(K)
- K802890CPS-10002Cleared 510(K)
- K803059INTERSEPT* VENOUS RESERVOIR BAG & HOLDER2Cleared 510(K)
- K802119SHILEY UTILITY RESERVOIR2Cleared 510(K)
- K790635Q220F CARDITOMY RESERVOIR/MODIFIED2Cleared 510(K)
- K781577DISPOSABLE CARDIOTOMY; H-700F, H-7002Cleared 510(K)
- K780517CARDIOTOMY RESERVOIR2Cleared 510(K)
- K770546BLOOD RESERVOIR2Cleared 510(K)
- K770036CARDIOTOMY RESERVOIR2Cleared 510(K)
- K760823TMO OXYGENATOR RESERVOIR PUMP SET2Cleared 510(K)
- DTPDefoamer, Cardiopulmonary Bypass2Product Code
- DTQConsole, Heart-Lung Machine, Cardiopulmonary Bypass2Product Code
- DTRHeat-Exchanger, Cardiopulmonary Bypass2Product Code
- DTSSucker, Cardiotomy Return, Cardiopulmonary Bypass2Product Code
- DTWMonitor And/Or Control, Level Sensing, Cardiopulmonary Bypass2Product Code
- DTXGas Control Unit, Cardiopulmonary Bypass2Product Code
- DTYSensor, Blood-Gas, In-Line, Cardiopulmonary Bypass2Product Code
- DTZOxygenator, Cardiopulmonary Bypass2Product Code
- DWAControl, Pump Speed, Cardiopulmonary Bypass2Product Code
- DWBPump, Blood, Cardiopulmonary Bypass, Roller Type2Product Code
- DWCController, Temperature, Cardiopulmonary Bypass2Product Code
- DWDSuction Control, Intracardiac, Cardiopulmonary Bypass2Product Code
- DWETubing, Pump, Cardiopulmonary Bypass2Product Code
- DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass2Product Code
- DWPDilator, Vessel, Surgical2Product Code
- DWQStripper, Vein, External2Product Code
- DWSInstruments, Surgical, Cardiovascular1Product Code
- DWXStripper, Artery, Intraluminal2Product Code
- DWZDevice, Biopsy, Endomyocardial2Product Code
- DXCClamp, Vascular2Product Code
- DXSGauge, Pressure, Coronary, Cardiopulmonary Bypass2Product Code
- JODFilter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass2Product Code
- JORGenerator, Pulsatile Flow, Cardiopulmonary Bypass3Product Code
- KFMPump, Blood, Cardiopulmonary Bypass, Non-Roller Type2Product Code
- KRIAccessory Equipment, Cardiopulmonary Bypass1Product Code
- KRJFilter, Prebypass, Cardiopulmonary Bypass2Product Code
- KRLDetector, Bubble, Cardiopulmonary Bypass2Product Code
- LXNProbe, Test, Heart-Valve1Product Code
- MCWCatheter, Peripheral, Atherectomy2Product Code
- MFYEndothelial Cell Harvesting Kit2Product Code
- MGZValvulotome2Product Code
- MJJCpb Check Valve, Retrograde Flow, In-Line2Product Code
- MJNCatheter, Intravascular Occluding, Temporary2Product Code
- MNJValve, Pressure Relief, Cardiopulmonary Bypass2Product Code
- MWSStabilizer, Heart1Product Code
- NCPCannula, Arterial, Cardiopulmonary Bypass (Cpb), Embolism Protection2Product Code
- NLJStripper, Vein, External, Reprocessed2Product Code
- NMFClamp, Vascular, Reprocessed2Product Code
- NQGStabilizer, Heart, Non-Compression, Reprocessed1Product Code
- OETCardioplegia Solution Administration Kit2Product Code
- OEUCardiopulmonary Bypass Catheter Kit2Product Code
- OFACardiovascular Surgical Instruments Tray1Product Code
- OFGCt Biopsy Tray2Product Code
- PNQApical Closure Device2Product Code
- PYXTemporary Non-Roller Type Right Heart Support Blood Pump3Product Code
- PTNReservoir, Blood, Cardiopulmonary Bypass, Exempt2Product Code
- PZSDual Lumen Ecmo Cannula2Product Code
- QJZExtracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure2Product Code
- QNRBlood Pump For Ecmo, Long-Term (> 6 Hours) Use2Product Code
- QOHExtracorporeal System For Carbon Dioxide Removal2Product Code
- QHWSingle Lumen Ecmo Cannula2Product Code
- QTFReprocessed Atherectomy Catheter2Product Code
- QWFTubing, Long Term Support Greater Than 6 Hours2Product Code
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Cardiovascular Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
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DIDECO FLEXIBLE RESERVOIR -- PRODUCT DESIGNATION 5063
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K945065
- 510(k) Type
- Traditional
- Applicant
- SORIN BIOMEDICAL, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 5/19/1995
- Days to Decision
- 217 days
- Submission Type
- Statement