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
- 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
- K250723FreedomFlow™ Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere Configuration)2Cleared 510(K)
- K250385Turbo-Elite Laser Atherectomy Catheter2Cleared 510(K)
- K242757Rotarex Atherectomy System2Cleared 510(K)
- K242947FreedomFlow™ Orbital Circumferential Atherectomy System2Cleared 510(K)
- K241553Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic Coating2Cleared 510(K)
- K233483FreedomFlow Orbital Circumferential Atherectomy System (H6004/5Fr 3-Sphere Configuration)2Cleared 510(K)
- K233668Auryon Atherectomy Catheter 1.5 mm XL, Hydrophilic Coating (EXM-4010-H000), Auryon Atherectomy Catheter 0.9 mm XL, Hydrophilic Coating (EXM-4011-H000), Auryon Atherectomy Catheter 1.5 mm XL (EXM -4010-0000), Auryon Atherectomy Catheter 0.9 mm XL (EXM-4011-0000)2Cleared 510(K)
- K231538FreedomFlow Orbital Circumferential Atherectomy System2Cleared 510(K)
- K230709Auryon Atherectomy System2Cleared 510(K)
- K230005Pantheris LV Atherectomy Catheter2Cleared 510(K)
- K222837Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters2Cleared 510(K)
- K220116Auryon Atherectomy Catheters2Cleared 510(K)
- K220962ROTAPRO Rotational Atherectomy System2Cleared 510(K)
- K221077Auryon Atherectomy System2Cleared 510(K)
- K220568Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System, Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series2Cleared 510(K)
- K220109DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System2Cleared 510(K)
- K212351Revolution Peripheral Atherectomy System2Cleared 510(K)
- K212047Pantheris System2Cleared 510(K)
- K211738Rotarex Atherectomy System2Cleared 510(K)
- K210586Diamonback 360 Peripheral Orbital Atherectomy System, Diamondback 360 Stealth Orbital Atherectomy system2Cleared 510(K)
- K212027TurboHawk Plus Directional Atherectomy System2Cleared 510(K)
- K2115182.4mm X 130cm Phoenix Deflecting Atherectomy System, 1.5mm X 149cm Phoenix Atherectomy System2Cleared 510(K)
- K202835Auryon Atherectomy System2Cleared 510(K)
- K203008DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System2Cleared 510(K)
- K191419Revolution Peripheral Atherectomy System, Revolution Peripheral Atherectomy Guidewire2Cleared 510(K)
- K190634Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System2Cleared 510(K)
- K182341Pantheris SV2Cleared 510(K)
- K182972Phoenix Atherectomy System2Cleared 510(K)
- K181877Phoenix 2.4mm Atherectomy Plus System2Cleared 510(K)
- K182397Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series2Cleared 510(K)
- K181642B-Laser Atherectomy System2Cleared 510(K)
- K173862Pantheris System2Cleared 510(K)
- K180416ViperWire Advance Guide Wire, Stealth 360 Orbital Peripheral Atherectomy Device (PAD), DIAMONDBACK 360 Peripheral Atherectomy System2Cleared 510(K)
- K172315Straub Endovascular System2Cleared 510(K)
- K180694Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters2Cleared 510(K)
- K172687Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters2Cleared 510(K)
- K172236Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox HS Imaging Console, Lightbox Sled2Cleared 510(K)
- K1723861.8mm X 149cm Phoenix Atherectomy System, 2.2mm X 149cm Phoenix Atherectomy System, 2.4mm X 130cm Phoenix Atherectomy System2Cleared 510(K)
- K170191SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excision System2Cleared 510(K)
- K170792Diamondback 360 Peripheral Orbital Atherectomy System2Cleared 510(K)
- K170059Spectranetics Turbo-Elite Laser Atherectomy Catheters2Cleared 510(K)
- K162561Turbo-Power (2.0mm) Laser Atherectomy Catheters2Cleared 510(K)
- K163264Pantheris Catheter (8F); Pantheris Cather (7F); Lightbox HS Imaging Console; Lightbox Sled2Cleared 510(K)
- K162326Pantheris Catheter, Lightbix HS Imaging Console, Lightbox Sled2Cleared 510(K)
- K161361HawkOne Directional Atherectomy System2Cleared 510(K)
- K160827Pantheris Catheter2Cleared 510(K)
- K153460Pantheris Catheter (8Fr), Pantheris Catheter (7Fr)2Cleared 510(K)
- K152181Turbo-Power Laser Atherectomy Catheter2Cleared 510(K)
- K152694Diamondback 360 Peripheral Orbital Atherectomy System2Cleared 510(K)
- K152275Pantheris System2Cleared 510(K)
- K151260ViperWire Advance Guide Wire, Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Orbital PAD2Cleared 510(K)
- K1511452.4mm X 127 cm Phoenix Atherectomy Deflecting System2Cleared 510(K)
- K150732Diamondback 360 Peripheral Orbital Atherectomy System2Cleared 510(K)
- K1433281.8mm X 149 cm Phoenix Atherectomy Catheter, 2.2mm X 149 cm Phoenix Atherectomy Catheter, Phoenix Handle, Phoenix Wire Support Clip2Cleared 510(K)
- K141801HAWKONE DIRECTIONAL ATHERECTOMY SYSTEM2Cleared 510(K)
- K133023JETSTREAM XC 2.4/3.4; JETSTREAM XC 2.1/3.0; JETSTREAM SC 1.85; JETSTREAM SC 1.62Cleared 510(K)
- K1409441.8 MM PHOENIX ATHERECTOMY CATHETER, 2.2 MM PHOENIX ATHERECTOMY CATHETER, PHOENIX HANDLE, PHOENIX WIRE SUPPORT CLIP2Cleared 510(K)
- K140775TURBO-ELITE ATHERECTOMY CATHETERS, TURBO TANDEM SYSTEM2Cleared 510(K)
- K133999DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM2Cleared 510(K)
- K132682PHOENIX 5F TRACKING ATHERECTOMY CATHETER, PHOENIX 6F TRACKING ATHERECTOMY CATHETER, PHOENIX 7D DEFLECTING ATHERECTOMY CA2Cleared 510(K)
- K133566ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM WITH THE PERIPHERAL ROTALINK PLUS2Cleared 510(K)
- K133399DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM2Cleared 510(K)
- K131092STEALTH 360 ORBITAL PAD SYSTEM2Cleared 510(K)
- K130637JETSTREAM XC 2.4/3.4 SYSTEM; JETSTREAM XC 2.1/3.0 SYSTEM; JETSTREAM SC 1.85 SYSTEM; JETSTREAM SC 1.6 SYSTEM2Cleared 510(K)
- K1236322.5MM TURBO ELITE 035, 2.3MM TURBO ELITE 0352Cleared 510(K)
- K122987STEALTH 360 ORBITAL PAD SYSTEM2Cleared 510(K)
- K122916JETSTREAM NAVITUS L SYSTEM JEYSTREAM NAVITUS SYSTEM JETSTREAM G3 SF SYSTEM JETSTREAM SF 1.6 SYSTEM2Cleared 510(K)
- K121774ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM WITH PERIPHERAL ROTALINK PLUS2Cleared 510(K)
- K120346CLEANER ROTATIONAL THROMBECTOMY SYSTEM2Cleared 510(K)
- K120242JETSTREAM NAVITUS L SYSTEM2Cleared 510(K)
- K111723TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEM2Cleared 510(K)
- K111388DIAMONDBACK 360* ORBITAL ATHERECTOMY SYSTEM, STEALTH 360* ORBITAL PAD SYSTEM2Cleared 510(K)
- K111229JETSTREAM G3 (R) SF 1.6 SYSTEM2Cleared 510(K)
- K110626JETSTREAM NAVITUS SYSTEM; JETSTREAM G3 SF SYSTEM; JETSTREAM G3 SE SYSTEM; JETSTREAM G3 L SYSTEM2Cleared 510(K)
- K110389STEALTH 360 ORBITAL PAD SYSTEM2Cleared 510(K)
- K103618TURBOHAWK PEROPHERAL PLAQUE EXCISION SYSTEM2Cleared 510(K)
- K101334JETSTREAM G3 SE SYSTEM, JETSTREAM G3 SF SYSTEM MODEL PV31230 (JETSTREAM G3 SE CATHETER AND CONTROL POD); PVCN100 (PV CON2Cleared 510(K)
- K101221JETSTREAM G3 SYSTEM, MODEL PV31300, PV CONSOLE, MODEL PVCN1002Cleared 510(K)
- K100462JETSTREAM G3 L SYSTEM, PV CONSOLE, MODELS PV31400, PV31300, PVCN1002Cleared 510(K)
- K091029CLEANER ROTATIONAL THROMBECTOMY SYSTEM (9 MM X 65 CM) AND (9 MM X 120 CM)2Cleared 510(K)
- K094036TURBO-TANDEM SYSTEM MODEL 472-1102Cleared 510(K)
- K093918JETSTREAM G3 L SYSTEM MODEL PV31400 (JETSTREAM G3 L CATHETER WITH CONTROL POD); PVCN100 (PV CONSOLE)2Cleared 510(K)
- K093456JETSTREAM G3 SYSTEM2Cleared 510(K)
- K093301TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEM2Cleared 510(K)
- K092332JETSTREAM G3 SYSTEM, MODEL PV31300 ( JETSTREAM G3 CATHETER AND CONTROL POD)., PVCN100 (PV CONSOLE)2Cleared 510(K)
- K091509JETSTREAM G2 NXT SYSTEM, MODEL PV203002Cleared 510(K)
- K090521DIAMONDBACK 360 DBX2Cleared 510(K)
- K090325JETSTREAM G2 SYSTEM, MODELS PV20300 (JETSTREAM G2 CATHETER AND CONTROL POD); PVCN100 (PV CONSOLE)2Cleared 510(K)
- K083489JETSTREAM PATHWAY PC ATHERECTOMY SYSTEM, MODEL OV103002Cleared 510(K)
- K083837JETSTREAM G2 SYSTEM, MODELS PV20300 (JETSTREAM G2 CATHETER AND CONTROL POD); PVCN100 (PV CONSOLE)2Cleared 510(K)
- K082981DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM WITH VIPERSLIDE LUBRICANT2Cleared 510(K)
- K082664JETSTREAM PATHWAY PV ATHERECTOMY SYSTEM, MODEL PV10300, PVCN1002Cleared 510(K)
- K082186MODIFICATION TO PATHWAY PV ATHERECTOMY SYSTEM2Cleared 510(K)
- K081944MODIFICATION TO DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM2Cleared 510(K)
- K081328PATHWAY PV ATHERECTOMY SYSTEM2Cleared 510(K)
- K071432SILVERHAWK-R PERIPHERAL PLAQUE EXCISION SYSTEM FOR SURGICAL USE2Cleared 510(K)
- K072748MODIFICATION TO: DIAMONDBACK 360 ORBITAL ATHERECTOMY SYSTEM2Cleared 510(K)
- K072800DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM2Cleared 510(K)
- K071427DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM FOR TREATMENT OF A-V SHUNT STENOSIS2Cleared 510(K)
- K072195THROMCAT THROMBECTOMY CATHETER SYSTEM2Cleared 510(K)
- K071350DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM2Cleared 510(K)
- K061188SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM2Cleared 510(K)
- K061063MODIFICATION TO: SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS P4028/FG083002Cleared 510(K)
- K060904CLEANER ROTATIONAL THROMBECTOMY SYSTEM2Cleared 510(K)
- K060016THROMCAT THROMBECTOMY CATHETER SYSTEM2Cleared 510(K)
- K053460MODIFICATION TO SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS 02550, 04800, 05200, 06002, 02406, 04706, 04300,2Cleared 510(K)
- K043553SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS 02550,04800, 05200, 02406, 04706, 043002Cleared 510(K)
- K041630ORBITAL ATHERECTOMY SYSTEM FOR TREATMENT OF A-V SHUNT STENOSIS2Cleared 510(K)
- K021096X-SIZER CATHETER SYSTEM2Cleared 510(K)
- K040252CLEANER ROTATIONAL THROMBECTOMY SYSTEM KIT2Cleared 510(K)
- K033997SOLERA PLUS THROMBECTOMY CATHETER, 55 CM AND 110 CM, MODELS BAC SMG 007 055, BAC SMG 007 1102Cleared 510(K)
- K033793CLEANER II ROTATIONAL THROMBECTOMY SYSTEM2Cleared 510(K)
- K030504AKONYA ELIMINATOR MECHANICAL THROMBECTOMY DEVICE, MODEL EL 100600602Cleared 510(K)
- K024243REFORM PERIPHERAL CATHETER SYSTEM, MODEL 02200; REFORM PERIPHERAL CATHETERCATHETER, MODEL 024062Cleared 510(K)
- K031610REX MEDICAL CLEANER ROTATIONAL THROMBECTOMY SYSTEM2Cleared 510(K)
- K022640SOLERA MAGNUM THROMBECTOMY CATHETER, 55 CM, MODEL BAC SMG 007 055 & SOLERA MAGNUM THROMBECTOMY CATHETER, 110 CM2Cleared 510(K)
- K013473XTD THROMBECTOMY CATHETER, XX CM, MODEL# CT000500X; XTD CONTROL CONSOLE, MODEL # CT0006001; XTD COLLECTION BOTTLE, MODEL2Cleared 510(K)
- K003570BACCHUS THROMBECTOMY CATHETER (BTC), MODEL BTC-07552Cleared 510(K)
- K993816BAXTER PERCUTANEOUS MECHANICAL THROMBECTOMY (PMT) DEVICE, MODELS PMT0606FD AND PMT1206FD2Cleared 510(K)
- K993564POSSIS ANGIOJET X-STREAM RHEOLYTIC THROMBECTOMY CATHETER, MODEL 103587-0022Cleared 510(K)
- K993648ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM WITH THE ROTALINK EXCHANGEABLE CATHETER2Cleared 510(K)
- K990829ARROW-TREROTOLA PERCUTANEOUS THROMBOLYTIC DEVICE OR PTD, MODELS PT-45509 (CATHETER KIT WITH INTRODUCER SHEATHS),PT-652Cleared 510(K)
- K982363OASIS THROMBECTOMY CATHETER SYSTEM2Cleared 510(K)
- K982657AMPLATZ THROMBECTOMY DEVICE MODELS ATD 601, ATD 602, ATD 801, ATD 802, FOOT PEDAL ASSEMBLY MODEL AK 1002Cleared 510(K)
- K973669THROMBOLYTIC BRUSH CATHETER, OVER THE WIRE (OTW)2Cleared 510(K)
- K970233GELBFISH ENDO-VAC SYSTEM2Cleared 510(K)
- K971984AMPLATZ THROMBECTOMY DEVICE(ATD 603,602,801,802)/FOOT PEDAL ASSEMBLY(AK 200)2Cleared 510(K)
- K970296ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM WITH THE ROTALINK EXCHANGEABLE CATHETER2Cleared 510(K)
- K963925THROMBOLYTIC BRUSH CATHETER2Cleared 510(K)
- K970080ARROW-TREROTOLA PTD CATHETER2Cleared 510(K)
- K960970POSSIS ANGIOJET RAPID THROMBECTOMY CATHETER SYSTEM, F105 CATHETER,MODEL 3030C,LF140 CATHETER,MODEL 3040C,PUMP SET 3020P2Cleared 510(K)
- K954205THE AMPLATZ THROMBECTOMY DEVICE2Cleared 510(K)
- K960379ROTABLATOR SYSTEM'S GUIDE WIRE LINE: SUPPORT ROTAWIRE RAIL ROTA WIRE2Cleared 510(K)
- K954604ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM ROTABLATOR SYSTEM'S GUIDE WIRE LINE; HTI FLOPPY2Cleared 510(K)
- K953997ROTABLATOR ROTATIONAL ANGIOPLASTY2Cleared 510(K)
- K942457GRAFT THROMBECTOMY INSTRUMENTS2Cleared 510(K)
- K935929MICROTRACK2Cleared 510(K)
- K933238ROTABLATOR, MODIFICATION2Cleared 510(K)
- K922970INTRA-OPERATIVE TEC ATHERECTOMY SYSTEM2Cleared 510(K)
- K924712ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM2Cleared 510(K)
- K920707HOLLOW MOTOR DRIVE UNIT W/ TORQUE CONTROLLER2Cleared 510(K)
- K915238TRAC-WRIGHT TRAC 10 CATHETER2Cleared 510(K)
- K913450HEART TECHNOLOGY ROTABLATOR WIRECLIP2Cleared 510(K)
- K904680THERATEK GROUP EXCHANGE CATHETER2Cleared 510(K)
- K901206ROTABLATOR2Cleared 510(K)
- 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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ROTABLATOR, MODIFICATION
- Page Type
- Cleared 510(K)
- 510(k) Number
- K933238
- 510(k) Type
- Traditional
- Applicant
- HEART TECHNOLOGY, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 8/24/1993
- Days to Decision
- 70 days
- Submission Type
- Statement