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
- 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
- K232577Radial Compression Device2Cleared 510(K)
- K230281PICOCLAMP2Cleared 510(K)
- K221661Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S)2Cleared 510(K)
- K230248VIOLA2Cleared 510(K)
- K222182Radial Artery Compression Tourniquets2Cleared 510(K)
- K221843GEM Biover Microvascular Clamps2Cleared 510(K)
- K213531TR BAND Radial Compression Device2Cleared 510(K)
- K210681SiteSeal SV2Cleared 510(K)
- K210324V. Mueller Cosgrove Flex Clamps, Model Number-CV1033, CV1061, CV1133, CV1161, CV11862Cleared 510(K)
- K210006MI DeTACH2Cleared 510(K)
- K203307VIOLA2Cleared 510(K)
- K203803VASOBand Vascular Compression Device2Cleared 510(K)
- K201695Patent Hemostasis Band (PH Band)2Cleared 510(K)
- K192413SiteSeal Femoral Compression Device2Cleared 510(K)
- K191827Sunmed Disposable Angio-Closure Pads2Cleared 510(K)
- K190351Site Seal SV2Cleared 510(K)
- K190318VASOBand Vascular Compression Device2Cleared 510(K)
- K180723PreludeSYNC DISTAL Radial Compression System2Cleared 510(K)
- K173563ARC ADJUSTABLE RADIAL CUFF COMPRESSION DEVICE2Cleared 510(K)
- K170958ChitoPulse 9in / 23 cm, ChitoPulse 12in / 30.5 cm, ChitoPulse 15in / 38 cm2Cleared 510(K)
- K163693IntraClude Intra-Aortic Occlusion Device2Cleared 510(K)
- K162988PreludeSYNC Radial Compression Device2Cleared 510(K)
- K162027TRAcelet Compression Device2Cleared 510(K)
- K161315Vein Clamps, Artery Clamps2Cleared 510(K)
- K153259VasoStat Hemostasis Device2Cleared 510(K)
- K152525TR BAND Radial Compression Device2Cleared 510(K)
- K151363Zephyr Vascular Compression Device2Cleared 510(K)
- K143078Bookwalter Gordon Adjustable Compression Element2Cleared 510(K)
- K150813iTClamp502Cleared 510(K)
- K141685CROC2Cleared 510(K)
- K142122RADAR VASCULAR COMPRESSION DEVICE2Cleared 510(K)
- K142359Vasc Band hemostat2Cleared 510(K)
- K140805ITCLAMP 502Cleared 510(K)
- K132293SYVEK RADIAL BAND2Cleared 510(K)
- K133029ABDOMINAL AORTIC AND JUNCTIONAL TOURNIQUET (AAJT) DEVICE2Cleared 510(K)
- K132651ITCLAMP 502Cleared 510(K)
- K131411COSEAL2Cleared 510(K)
- K132175EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC CATHETER2Cleared 510(K)
- K123571CARDIO VISION MICS AORTIC CLAMPS2Cleared 510(K)
- K131561SAM JUNCTIONAL TOURNIQUET2Cleared 510(K)
- K130382HEARTSTRING III PROXIMAL SEAL SYSTEM2Cleared 510(K)
- K123041VASOSTAT HEMOSTASIS DEVICE2Cleared 510(K)
- K123551ITCLAMP 502Cleared 510(K)
- K123077VASCULAR CLAMPS2Cleared 510(K)
- K130482COMBAT READY CLAMP2Cleared 510(K)
- K130124CATALYST II AND III2Cleared 510(K)
- K123694SAM JUNCTIONAL TOURNIQUET2Cleared 510(K)
- K123194JUNCTIONAL EMERGENCY TREATMENT TOOL MODEL 30-00882Cleared 510(K)
- K123035SEAL ONE2Cleared 510(K)
- K122405AIR-BAND RADIAL COMPRESSION DEVICE2Cleared 510(K)
- K120492K2 MEDICAL VASCULAR CLAMPS2Cleared 510(K)
- K113600IM BAND2Cleared 510(K)
- K112662MICROFRANCE(R) WORMALD VASCULAR CLAMP2Cleared 510(K)
- K113182EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC CATHETER2Cleared 510(K)
- K112384ABDOMINAL TOURNIQUET SYSTEM2Cleared 510(K)
- K112694EDWARDS LIFESCIENCES ENDOCLAMP AORTIC CATHETER2Cleared 510(K)
- K111837RADIAL ARTERY COMPRESSION TOURNIQUET2Cleared 510(K)
- K110148WEXLER VASCULAR CLAMP SERIES2Cleared 510(K)
- K110193FEMOSTOP PLYS, FEMOSTOP HD, FEMOSTOP COMPRESSION ARCH; FEMOSTOP II PLUS SET; FEMOSTOP II PLUS ARCH, BILATERAL ADAPTER; F2Cleared 510(K)
- K102048ATRAUMATIC VASCULAR CLAMPS2Cleared 510(K)
- K102025COMBAT READY CLAMP2Cleared 510(K)
- K092503RADAR VASCULAR COMPRESSION DEVICES2Cleared 510(K)
- K092544INSTRUMED VASCULAR CLAMPS2Cleared 510(K)
- K090286PRESSUREMATE MANUAL FEMORAL ACCESS COMPRESSION DEVICE2Cleared 510(K)
- K082930CARDIVA CATALYST III SYSTEM WITH PROTAMINE SULFATE2Cleared 510(K)
- K080206MODIFICATION TO FEMOSTOP FEMORAL COMPRESSION SYSTEM2Cleared 510(K)
- K080169HEARTSTRING III PROXIMAL SEAL SYSTEM2Cleared 510(K)
- K072834SIBEL SA VASCULAR CLAMP2Cleared 510(K)
- K072297BOOMERANG CATALYST/BOOMERANG CATALYST II SYSTEM2Cleared 510(K)
- K072167COMFORTPRESS VASCULAR COMPRESSION ASSIST DEVICE2Cleared 510(K)
- K071225INNOVASA STAT*SEAL TOPICAL HEMOSTAT2Cleared 510(K)
- K070661VITALCOR FEATHERWEIGHT VASCULAR CLAMPS2Cleared 510(K)
- K070380PORTACLAMP FLEX2Cleared 510(K)
- K070423TR BAND2Cleared 510(K)
- K070485BOOMERANG WIRE /BOOMERANG PLUS WIRE SYSTEM, MODEL# B PLUS WIRE 58L2Cleared 510(K)
- K063871D-STAT HANDLE, MODEL 8500-0532Cleared 510(K)
- K070323TEMPORARY LIMB SALVAGE SHUNT2Cleared 510(K)
- K062569SAFEGUARD 24 CM PRESSURE ASSISTED DRESSING2Cleared 510(K)
- K061484MODIFICATION TO: SMITHWICK CAROTID SHUNT2Cleared 510(K)
- K051817BOOMERANG CLOSUREWIRE VASCULAR CLOSURE SYSTEM2Cleared 510(K)
- K062474SMITHWICK CAROTID SHUNT2Cleared 510(K)
- K061075BOOMERANG WIRE2Cleared 510(K)
- K053300SYVEKEXCEL2Cleared 510(K)
- K053398COMPASS COMPRESSION ASSIST HANDLE2Cleared 510(K)
- K050146VASCULAR SOLUTIONS D-STAT CLAMP ACCESSORY2Cleared 510(K)
- K041486VASOSTASIS VASCULAR CLOSURE SYSTEM2Cleared 510(K)
- K040730VASCULAR SOLUTIONS D-STAT CLAMP HEMOSTATIC CLAMP2Cleared 510(K)
- K040615COMPRESSAR SUPERCOMFORT DISC AND STRONGARM SUPERCOMFORT SYSTEM2Cleared 510(K)
- K033085PORTACLAMP2Cleared 510(K)
- K032125CSTAT, MODELS 09-0014-01 AND 09-0014-022Cleared 510(K)
- K031812TRANSVAGINAL DOPPLER CLAMP, MODELS: 09-0016-01, 09-0016-02, 09-0016-032Cleared 510(K)
- K032589ENCLOSE II ANASTOMOSIS ASSIST DEVICE2Cleared 510(K)
- K023682ENCLOSE ANASTOMOSIS ASSIST DEVICE2Cleared 510(K)
- K024107FEMOSTOP FEMORAL COMPRESSION SYSTEM2Cleared 510(K)
- K023154VCS-A SERIES CLAMP WITH DOPPLER ULTRASOUND, MODEL 09-0007-01 AND 09-0007-022Cleared 510(K)
- K014277KSEA DEPLOYABLE CARDIOVASCULAR CLAMP2Cleared 510(K)
- K021608SMITHWICK CAROTID SHUNT2Cleared 510(K)
- K022754S&T SINGLE USE MICRO ANASTOMOSIS CLAMP2Cleared 510(K)
- K011208BIOVER2Cleared 510(K)
- K022880GUIDANT PROXIMAL SEAL SYSTEM, MODELS PSS-4500 & PS-45002Cleared 510(K)
- K010727FLEXLINE CLAMP2Cleared 510(K)
- K012041THE HAMMER MODEL H1002Cleared 510(K)
- K011863VCS-A SERIES CLAMP2Cleared 510(K)
- K010694INCLUDER CLAMP2Cleared 510(K)
- K010785KSEA DION-GRACIA SET2Cleared 510(K)
- K011078MALLEABLE SHAFT CLAMP2Cleared 510(K)
- K010117GUIDANT AXIUS CORONARY SHUNT2Cleared 510(K)
- K002915FLEXIBLE OCCLUSION SYSTEM2Cleared 510(K)
- K002767COMPRESSAR FEMORAL ACCESS COMPRESSION DEVICE2Cleared 510(K)
- K992980ENGAGE JAW INSERTS2Cleared 510(K)
- K000098SOFTLINE SPRING CLIP2Cleared 510(K)
- K992174PILLING WECK SURGICAL AORTIC SPOON-JAW CLAMP2Cleared 510(K)
- K992053AESCULAP VASCULAR INSTRUMENTS2Cleared 510(K)
- K992640SLIMLINE SURGICAL CLAMP; SLIMLINE JAW INSERTS2Cleared 510(K)
- K984214CORDIS ENDOVASCULAR TEMPORARY OCCLUSION BALLOON CATHETER2Cleared 510(K)
- K991589FLEXIBLE VASCULAR CLAMP, VERSION 22Cleared 510(K)
- K982365ATRAUMATIC VASCULAR CLAMPS, MODEL #'S 22-XXXX, 23-XXXX, 03-60XX, 25-XXXX MICRO VASCULAR CLAMPS MODEL # 75-0XXX, ATRAUMAT2Cleared 510(K)
- K982278MICRINS MICRO ANASTOMOSIS CLAMP2Cleared 510(K)
- K990573ESTECH ARTERIAL REMOTE ACCESS PERFUSION CANNULA2Cleared 510(K)
- K983471FEMOSTOP COMPRESSION ARCH, FEMOSTOP PUMP, FEMOSTOP BILATERAL ADAPTER2Cleared 510(K)
- K980631EMBOL-X AORTIC OCCLUSION AND CARDIOPLEGIA CANNULA2Cleared 510(K)
- K982182FEMOSTOP II PLUS DISPOSABLE SET MODEL 11166, FEMOSTOP II PLUS COMPRESSION ARCH MODEL 11168, FEMOSTOP II BILATERAL ADAPT02Cleared 510(K)
- K972689CAOW HEMOSTASIS SYSTEM2Cleared 510(K)
- K981624FLO-THRU2Cleared 510(K)
- K980128BALADI INVERTER WITH COAXIAL AORTIC PUNCH2Cleared 510(K)
- K981956DEGANIA SILICONE IDENTI LOOPS2Cleared 510(K)
- K980087PRESDURE PRODUCTS PRESSURE PADS, MODELS P100, P110, P120, P130, P200, P210, P220, P230, P300, P310, P320, P3302Cleared 510(K)
- K980002KOALA VASCULAR CLAMPS AND INSERTS2Cleared 510(K)
- K974769COSGROVE CLAMP2Cleared 510(K)
- K980898FEMOSTOP II DISPOSABLE SET, FEMOSTOP II COMPRESSION ARCH, FEMOSTOP II PUMP, FEMOSTOP II BILATERAL ADAPTER2Cleared 510(K)
- K973080SURGICAL VASCULAR CLAMP2Cleared 510(K)
- K973132EZ HOLD 1 LBS., EZ HOLD 2 LBS2Cleared 510(K)
- K964663FAVP: FEMORAL ARTERY VASCULAR PAD - MODEL NUMBER PAD2EK-01, PAD2EK-2X, PAD5EK-R, PAD5EK-RX, PAD6EK-F AND PAD6EK-FX2Cleared 510(K)
- K973216FAVC-HH: FEMORAL ARTERY VASCULAR CLAMP-HAND HELD: 1/2 & 3 POUNDS (RMDS810T/815T/820T)2Cleared 510(K)
- K970638CTS MIDCAB FIXEDN DIAMETER CORONARY SHUNT2Cleared 510(K)
- K970611ORIGIN CARDIAC STABLIZER OCCLUDER2Cleared 510(K)
- K970027FAVC-M: FEMORAL ARTERY VASCULAR CLAMP-MOBILE (MODEL M100-M200) FAVC-M FEMORAL ARTERY VASCULAR CLAMP-MOBILE ADJ BELT 60052Cleared 510(K)
- K964251OCCLUSION CLAMP** DEVICE2Cleared 510(K)
- K964161HEARTPORT ENDOAORTIC CLAMP2Cleared 510(K)
- K963503CTS MIDCAB CORONARY SHUNT2Cleared 510(K)
- K963716MICS DEVICE SYSTEM2Cleared 510(K)
- K964662FAVC: FEMORAL ARTERY VASCULAR CLAMP - MODEL NUMBER RMDS 1000-15, RMDS 1000-20, RMDS 2000-15, RMDS 2000-20, RMDS 3000-152Cleared 510(K)
- K964547DEGANIA SILICONE INDENTI LOOPS2Cleared 510(K)
- K962366HEARTPORT CABLE BULLDOG CLAMP2Cleared 510(K)
- K962668AMR-ACV CLAMPS2Cleared 510(K)
- K955827DANESHVAR WOUND SUPPORT UNIT2Cleared 510(K)
- K962858HEARTPORT ENDOVASCULAR CARDIOPULMONARY BYPASS SYSTEM ANTEGRADE SYTEM (CATALOG NUMBER ECPB-A) ANTEGRADE/RETROGRADE SYSTEM2Cleared 510(K)
- K962510HEARTPORT ENDOAORTIC CLAMP2Cleared 510(K)
- K955742D. DEVICE II2Cleared 510(K)
- K955270TAPE & BANDAGE, ADHESIVE2Cleared 510(K)
- K961461DANESHVAR'S DEVICE (MODIFICATION)2Cleared 510(K)
- K961100MICRO ANASTOMOSIS CLAMP2Cleared 510(K)
- K955132HEARTPORT ENDOAORTIC CLAMP2Cleared 510(K)
- K954669FEMOSTOP, FEMOSTOP PUMP2Cleared 510(K)
- K951413FOGARTY-HYDRAGRIP SURGICAL CLAMPS2Cleared 510(K)
- K944259FEMOSTOP II2Cleared 510(K)
- K943948PROTECTIVE SHORTS2Cleared 510(K)
- K950492ATRAUMAX SURGICAL CLAMP2Cleared 510(K)
- K935964IDEAS OCCLUDER2Cleared 510(K)
- K935494DANESHVAR'S DEVICE2Cleared 510(K)
- K942812FLO-RESTER DISPOSABLE VESSEL OCCLUDER2Cleared 510(K)
- K925809COMPRESSAR UNIVERSAL (TM) SYSTEM2Cleared 510(K)
- K923085QUICKLAMP SYSTEM2Cleared 510(K)
- K920936RMI EXTERNAL CORONARY ARTERY OCCLUDER2Cleared 510(K)
- K921399OCCLUSION BALLON CATHETER MODIFICAION2Cleared 510(K)
- K920501SILCLAMPS DEGANIA SILICONE2Cleared 510(K)
- K915280FEMOSTOP2Cleared 510(K)
- K914149FEMORAL ARTERY PRESSURE PAD/DISK2Cleared 510(K)
- K910221RMI VASCULAR TOURNIQUET KIT2Cleared 510(K)
- K901628APPLIED VASCULAR DEVICES 6MM TRACTION CLIP2Cleared 510(K)
- K901565ATRAUMAX SURGICAL CLAMP MODEL FOG-5048, 75MM SIDE2Cleared 510(K)
- K897075PTI INTRA-ART(TM) ANSARI SAPHENOUS VEIN HOLDER2Cleared 510(K)
- K885161VOSS VEIN CLAMP2Cleared 510(K)
- K895691VASCULAR CLAMP2Cleared 510(K)
- K894670GENERAL SURGICAL INSTRUMENTS2Cleared 510(K)
- K891296ATRAUMAX(TM) SURGICAL CLAMPS2Cleared 510(K)
- K883790SURGICAL CLAMP INSERTS2Cleared 510(K)
- K883696FLO-RESTER2Cleared 510(K)
- K882879PTI INTRA-ART(TM) CORONARY ARTERY OCCLUDERS (STER)2Cleared 510(K)
- K881448#557 DISPOSABLE CARDIOVASCULAR CLAMP2Cleared 510(K)
- K881447METATECH METAL MICROCLIP2Cleared 510(K)
- K881158VASCULAR CLAMP2Cleared 510(K)
- K875090AUTO SUTURE DISPOSABLE APPROXIMATING CLAMP*2Cleared 510(K)
- K863427CLAMPEASE FA2Cleared 510(K)
- K861924MICRO ANASTOMOSIS CLAMP2Cleared 510(K)
- K851739DUNN VESSEL OCCLUDER-STERILE2Cleared 510(K)
- K852479PULMONARY VEIN CLAMP2Cleared 510(K)
- K831809FOGARTY OCCLUDER PAD2Cleared 510(K)
- K832554FOGARTY 6MM SOFTJAW CLIP2Cleared 510(K)
- K820949P-S BERLIN VESSEL CLAMP2Cleared 510(K)
- K813499OMED DISPOSABLE BULLDOG2Cleared 510(K)
- K813062VASCULAR PAWS2Cleared 510(K)
- K810162FOGARTY SOFTJAW 6MM SPRING CLIP, #614-062Cleared 510(K)
- K802244VESSEL RETRACTOR, #6007322Cleared 510(K)
- K801395VASCULAR CLAMP2Cleared 510(K)
- K791098SINGLE-USE MINI-BULLDOG2Cleared 510(K)
- K772137VEIN CLAMPS2Cleared 510(K)
- K770503LOUISVILLE CLAMP PRODUCT #65-1722Cleared 510(K)
- K761169GRANT MODIF OF DEBAKEY ABDOM AORTA CLMP2Cleared 510(K)
- 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
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
HEARTPORT ENDOAORTIC CLAMP
- Page Type
- Cleared 510(K)
- 510(k) Number
- K964161
- 510(k) Type
- Traditional
- Applicant
- HEARTPORT, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 4/4/1997
- Days to Decision
- 169 days
- Submission Type
- Summary