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
- DSTClip, Vena-Cava2Product Code
- DSWBag, Polymeric Mesh, Pacemaker1Product Code
- DSYProsthesis, Vascular Graft, Of 6mm And Greater Diameter2Product Code
- DSZPacemaker Battery3Product Code
- DTATester, Pacemaker Electrode Function2Product Code
- DTBPermanent Pacemaker Electrode3Product Code
- DTCAnalyzer, Pacemaker Generator Function2Product Code
- DTDPacemaker Lead Adaptor2Product Code
- DTEPulse-Generator, Pacemaker, External2Product Code
- DTFTools, Pacemaker Service1Product Code
- DTGMagnet, Test, Pacemaker1Product Code
- DTISizer, Heart-Valve, Prosthesis1Product Code
- DTJHolder, Heart-Valve, Prosthesis1Product Code
- DTKFilter, Intravascular, Cardiovascular2Product Code
- DSPSystem, Balloon, Intra-Aortic And Control2Product Code
- K250542AC3™ Range™ Intra-Aortic Balloon Pump2Cleared 510(K)
- K232343AC3™ Series IABP2Cleared 510(K)
- K201112AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABP2Cleared 510(K)
- K200634Arrow FiberOptix Intra-Aortic Balloon Catheter Kit2Cleared 510(K)
- K192238AC3 Series Intra-Aortic Balloon Pump (IABP)2Cleared 510(K)
- K190101UltraFlex IAB2Cleared 510(K)
- K190117Fiberoptix IAB2Cleared 510(K)
- K181122CARDIOSAVE Intra-Aortic Balloon Pump2Cleared 510(K)
- K172305CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon Pump2Cleared 510(K)
- K162820AC3 Series IABP System2Cleared 510(K)
- K163542CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Storage Case2Cleared 510(K)
- K151254CARDIOSAVE Hybrid Intra-Aortic Balloon Pump2Cleared 510(K)
- K133074MEGA 8FR. 50CC AND SENSATION PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETERS AND ACCESSORIES2Cleared 510(K)
- K122628SENSATION PLUS 7.5FR. 40CC INTRA-AORTIC BALLOON (IAB) CATHETER AND ACCESSORIES2Cleared 510(K)
- K120868MEGA(TM) 7.5FR. 30CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MEGA(TM) 7.5FR. 40CC INTRA-AORTIC BALLOON CATHETER2Cleared 510(K)
- K112372CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP2Cleared 510(K)
- K112327SENSATION(TM) PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES2Cleared 510(K)
- K091449DATASCOPE'S 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MODELS 0684,00-0498-01, 022Cleared 510(K)
- K082746ULTRA IABP CATHETER KIT, MODELS IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25, IMU7F-202Cleared 510(K)
- K070225SUPRACOR INTR-AORTIC BALLOON PUMP CONSOLE2Cleared 510(K)
- K063525DATASCOPE FIBER OPTIC PRESSURE SENSOR INTRA-AORTIC BALLOON CATHETER AND CS300 INTRA-AORTIC BALLOON PUMP CONTROL SYSTEM2Cleared 510(K)
- K062582SUPRACOR BALLOON CATHETER2Cleared 510(K)
- K060309AUTOCAT INTRA-AORTIC BALLOON PUMP SERIES2Cleared 510(K)
- K041281DATASCOPE 7.5FR. IAB CATHETER AND ACCESSORIES2Cleared 510(K)
- K040801INTRA-AORTIC BALLOON (IAB)2Cleared 510(K)
- K031636CS100 INTRA-AORTIC BALLOON PUMP, MODEL 0998-00-3013-XX2Cleared 510(K)
- K031569DATASCOPE CA 40 8FR. IABS, MODEL 0684-00-04XX2Cleared 510(K)
- K021462ARROW INTRA-AORTIC BALLOON (IAB) CATHETER WITH A FIBER OPTIC SENSOR AND A MEASUREMENT SYSTEM, MODELS IAB-05830-F,IAB58402Cleared 510(K)
- K020257DATASCOPE'S 8FR. ALT B IAB; DATASCOPE'S PROFILE 8FR. ALT B IAB; DATASCOPE'S TRUE SHEATHLESS DL 9.5 FR. IAB; DATASCOPE'S2Cleared 510(K)
- K013326MODIFICATION TO: DATASCOPE 8FR. POLYIMIDE ALT B IAB, 25CC, 34CC, 40CC, DATASCOPE INSERTION KIT FOR 8 FR, POLYIMIDE ALT B2Cleared 510(K)
- K002256ARROW ACAT 2 INTRA-AORTIC BALLOON PUMP2Cleared 510(K)
- K010330ARROW REDIGUARD, 9FR. 50CC, INTRA-AORTIC BALLOON VATHETER, IAB-R950-U2Cleared 510(K)
- K003598DATASCOPE PROFILE 8FR. ALT B IAB, 34CC, DATASCOPE PROFILE 8FR. ALT B IAB, 40CC, MODEL 0684-000319, 0684-00-03202Cleared 510(K)
- K002949MODIFICATION TO DATASCOPE PROFILE 8FR. IAB, 34CC; MODIFICATION TO DATASCOPE PROFILE 8FR. IAB, 40CC2Cleared 510(K)
- K000729ARROW ULTRA 8 INTRA-AORTIC BALLOON CATHETERS (IABS) 8FR 30CC AND 40CC UNIVERSAL2Cleared 510(K)
- K994157DATASCOPE'S 8FR. POLYMIDE 25CC,34CC AND 40CC IAB AND ACCESSORIES, MODELS 0684-00-0327, 06844-00-0328, 0684-00-03292Cleared 510(K)
- K9939668FR. NARROWFLEX UNIVERSAL INTRA-AORTIC BALLOON CATHETER2Cleared 510(K)
- K983866BELMONT MODEL NGPBP INTRA-AORTIC BALLOON PUMP2Cleared 510(K)
- K981660Bard 8 Fr., 40cc. & 7Fr., 30cc Intra-Aortic Balloon Catheters2Cleared 510(K)
- K982538BELMONT PORTABLE BALLOON PUMP, BARD TRANSACT IABP2Cleared 510(K)
- K970689IAB-04840-U;IAB-04250-U;IAB-04240-U;IAB-04230-U2Cleared 510(K)
- K980850BARD 9FR., 40CC. REDIGUARD AND TAPERSEAL INTRA-AORTIC BALLOONS2Cleared 510(K)
- K980780DATASCOPE PERCOR STAT-DL 9.5 FR. 25, 34 AND 40CC INTRA-AORIC BALLOONS WITH ALTERNATE B MEMBRANE FOR OPTIONAL SHEATHLES2Cleared 510(K)
- K980385DATASCOPE 8FR. CO-LUMEN 34 AND 40CC INTRA-AORTIC BALLOON CATHETERS FOR OPTIONAL SHEATHLESS INSERTION WITH ACCESSORIES2Cleared 510(K)
- K973962BARD 9FR., 30CC REDIGUARD AND TAPERSEAL BALLOONS2Cleared 510(K)
- K97424740 CC GRANDE2Cleared 510(K)
- K965209ACAT 1 (ARROW CARDIAC ASSIST TECHNOLOGY 1)2Cleared 510(K)
- K9638658 FR. -30CC NARROWFLEX SHEATHLESS INTRA-AORTIC BALLOON CATHETER, PRODUCT NUMBER IAB-04830S2Cleared 510(K)
- K97211330 CC AND 40 CC SUB-9 NITINOL AND 30 AND 40 CC SUB-9 STAINLESS STEEL2Cleared 510(K)
- K97167340 CC SUMO2Cleared 510(K)
- K965236SYSTEM 96 INTRA-AORTIC BALLOON PUMP (IABP)2Cleared 510(K)
- K9639208 FR.-30CC NARROWFLEX INTRA-AORTIC BALLOON CATHETER,2Cleared 510(K)
- K964987DATASCOPE PERCOR STAT - DL 9.5 FR. 25 AND 40CC INTRA-AORTIC BALLOON FOR OPTIONAL SHEATHLESS INSERTION AND PERCOR STAT -02Cleared 510(K)
- K9631049.5 FR.- FLEXI-CATH INTRA-AORTIC AND CONTROL SYSTEM2Cleared 510(K)
- K961509INTRA-AORTIC BALLOON PUMP SYSTEM 97 MODIFIED2Cleared 510(K)
- K963187MODIFIED LABELING OF CARDIAC ASSIST INTRA-AORTIC BALLOON CATHETERS: MODEL 930 - 940, 30 - 40 CC SENSATION AND NICATH 30C2Cleared 510(K)
- K962177BARD TAPERSEAL INTRA-AORTIC BALLOON CATHETER & INTRODUCER KIT2Cleared 510(K)
- K961358ARROW SHEATHLESS INTRA-AORTIC BALLOON CATHETER2Cleared 510(K)
- K9607138 FR.-40CC ARROW FLEX INTRA-AORTIC BALLOON CATHETER WITH BLUE FLEX TIP, PRODUCT NUMBER IAB-04840(USED WITH A 9FR.SHEATH)2Cleared 510(K)
- K960166PERCOR STAT-DL 9.5 FR. 34 & 40CC2Cleared 510(K)
- K954431PERCUTANEOUS INTRA-AORTIC BALLOON CATHETERS2Cleared 510(K)
- K952576TRANSPORT CART2Cleared 510(K)
- K952221BSC/CA 30 & 40 SENSATION, MODELS 930 & 9402Cleared 510(K)
- K950687EXTERNAL HELIUM SUPPLY (ACCESSORY FOR IABP)2Cleared 510(K)
- K945230ARROW KINK RESISTANT FLEXI-CATH INTRA-AORTIC BALLOON2Cleared 510(K)
- K940298BSC/CA MODEL 940 IAB2Cleared 510(K)
- K9439199.5 FR SENSATION DL INTRA-AORTIC BALLON CATHETER2Cleared 510(K)
- K942454DATASCOPE 95 AND 97 IAB PUMP CONSOLE2Cleared 510(K)
- K935184REDIFURL AND TEPERSEAL DL INTRA-AORTIC BALLOON CATHETERS WITH HYDROMER COATING2Cleared 510(K)
- K944460DATASCOPE INTRA-AORTIC BALLOON WITH MODIFIED STAT GARD2Cleared 510(K)
- K936232BSC/CA MODEL 930 IAB, BSC/CA 30 SIDEWINDER2Cleared 510(K)
- K940231INTRA-AORTIC BALLOON FOR OPTIONAL SHEATHLESS INSERTION2Cleared 510(K)
- K940178PERCOR STAT-DL 9.5 FR.34CC & 40CC /PERCOR STAT-DL 10.5 FR.40CC & 50CC INTRA-AORTIC BALLOON MODIFICATION2Cleared 510(K)
- K932268MODIFICATIONS TO INTRA-AORTIC BALLOONS2Cleared 510(K)
- K925248MODIFICATION OF INTRA-AORTIC BALLOON CATHETERS2Cleared 510(K)
- K9260009.5 FR SIDEWINDER DL INTRA-AORTIC BALLON CATHETER2Cleared 510(K)
- K914802DATASCOPE PERCOR STAT DL9.5 FR34CC INTRA-AORT BALL2Cleared 510(K)
- K911000PERCOR STAT DL 8.5 FR 40CC INTRA-AORTIC BALLOON2Cleared 510(K)
- K920427PERCOR STAT DL 9.5 FR 40CC INTRA-AORTIC BALLOON2Cleared 510(K)
- K905663PEDIATRIC INTRA-AORTIC BALLOON CATHETERS2Cleared 510(K)
- K922235SYSTEM 972Cleared 510(K)
- K924382BARD(R) INTRA AORTIC BALLOON2Cleared 510(K)
- K921638SYSTEM 90 INTRA-AORTIC BALLOON PUMP CONSOLE2Cleared 510(K)
- K915580BELMONT MODEL PBP INTRA-AORTIC BALLOON PUMP2Cleared 510(K)
- K913847SYSTEM 90 AND SYSTEM 90T2Cleared 510(K)
- K912629DATASCOPE SYSTEM 952Cleared 510(K)
- K910997DATASCOPE PERCOR STAT INTRA-AORTIC BALLOON2Cleared 510(K)
- K905313KONTRON INTRA-AORTIC BALLOON PUMP, MODEL KAAT II2Cleared 510(K)
- K905056PERCOR STAT-DL 9.5 FR W/OPT INSERT W/O INTRO SHEAT2Cleared 510(K)
- K903917COMPACT MONITOR SMK 210,211,230,231,2402Cleared 510(K)
- K9033449.5 FR PERCUTANEOUS DB LUMEN 40CC FLEXI-CATH (TM)2Cleared 510(K)
- K903930DATASCOPE PERCOR STAT DL 10.5 FR 50CC2Cleared 510(K)
- K904414DATASCOPE PERCOR STAT DL 9.5 FR40CC STERIL ETO GAS2Cleared 510(K)
- K904018DATASCOPE PERCOR STAT DL 9.5 FR 40CC INTRA-AOR BAL2Cleared 510(K)
- K903893DATASCOPE PERCOR STAT 9.5 FR 40CC INTRA-AORTIC BAL2Cleared 510(K)
- K903892DATASCOPE PERCOR STAT 8.5 FR 40CC INTRA-AORTIC BAL2Cleared 510(K)
- K903867DATASCOPE PERCOR STAT DL 10.5 FR 40CC2Cleared 510(K)
- K903769PERCOR STAT DL 9.5 FR 34CC INTRA-AORTIC BALLOON2Cleared 510(K)
- K903736DATASCOPE PERCOR STAT DL10.5 FR40CC IN AORTIC BAL2Cleared 510(K)
- K902057PERCOR STAT DL 8.5 FR 40CC IAB ONLY/LABELING CHANG2Cleared 510(K)
- K8922229.5F PERCU DOUBLE LUMEN INTRA-AORTIC BALLOON2Cleared 510(K)
- K896497PERCOR STAT-DL 8.5 FR INTRA-AORTIC BALLOON2Cleared 510(K)
- K900281SERIES 3001 IABP2Cleared 510(K)
- K895433ARIES 30CC & 50CC INTRA-AORTIC BALLOON & CONT. SYS2Cleared 510(K)
- K896920SIDEWINDER 40CC DL INTRA-AORTIC BALLOON CATHETER2Cleared 510(K)
- K896597THE SIDEWINDER 40CC DL INTRA-AORTIC BALLOON CATH.2Cleared 510(K)
- K896430PERCOR STAT-DL 9.5 FR & STAT-SL 8.5 FR INTRA-AORTI2Cleared 510(K)
- K894942SIDEWINDER 40CC DL INTRA-AORTIC BALLOON CATHETER2Cleared 510(K)
- K8927998 FR PERCUTAN DOUBLE LUMEN INTRA-AORTIC BALLOON2Cleared 510(K)
- K89279710 FR PERCUTAN DOUBLE LUMEN INTRA-AORTIC BALLOON2Cleared 510(K)
- K8927989 FR PERCUTAN DOUBLE LUMEN INTRA-AORTIC BALLOON2Cleared 510(K)
- K892878KONTRON INTRA-AORTIC BALLOON PUMP MODEL K90002Cleared 510(K)
- K893243INTRA AORTIC BALLOON2Cleared 510(K)
- K8825089.5 FRENCH PERCUTANEOUS DOUBLE LUMEN BALLOON2Cleared 510(K)
- K88227410.5 FRENCH PERCUTANEOUS DOUBLE LUMEN INTRA-AORTIC2Cleared 510(K)
- K880289DATASCOPE PERCOR STAT-MIL 9.5 FR INTRA-AORTIC BALL2Cleared 510(K)
- K875036INTRA-AORTIC BALLOON PUMP MODEL KAAT2Cleared 510(K)
- K874816KONTRON INTRA-AORTIC BALLOON PUMP MODEL K20002Cleared 510(K)
- K86499440CC PER. PRE-FURL (S/L) INTRA-AORTIC CATHETER2Cleared 510(K)
- K86453740CC PERCUTANEOUS PRE-FURL (D/L) BALLOON CATHETER2Cleared 510(K)
- K86456840CC SURGICAL DOUBLE LUMEN BALLOON CATHETER2Cleared 510(K)
- K86456740CC PERCUTANEOUS FURL DOU. LUMEN BALLOON CATHETER2Cleared 510(K)
- K86318540CC PERCUTANEOUS FURL SINGLE INTRA-AORTIC BALLOON2Cleared 510(K)
- K863219SYSTEM 90 TRANSPORT2Cleared 510(K)
- K860638NOVEMPERC DOUBLE LUMEN INTRA-AORTIC BALLOON2Cleared 510(K)
- K855102MONARK 869 ERGOMETER2Cleared 510(K)
- K860427KONTRON INTRA-AORTIC BALLOON PUMP MODEL KAAT2Cleared 510(K)
- K853062INTRA-AORTIC BALLOON PUMP MODEL K20002Cleared 510(K)
- K840367PRESSURE TRIGGER MOD OF SMEC INTRA-AORT2Cleared 510(K)
- K850482DATASCOPE 8.5 FRENCH ELECTRODE INTRA-AORTIC BALLOO2Cleared 510(K)
- K844220ARIES MEDICAL PERFLEX PERCUTANEOUS 40CC D/L BALLOO2Cleared 510(K)
- K833828PERCOR 9.5 FR IAB ON DATASCOPE CO22Cleared 510(K)
- K831235IABP #90 SYSTEM2Cleared 510(K)
- K840037MODIFIED SMEC PERCUTANEOUS INTRA-AORTIC2Cleared 510(K)
- K832753PERCUTANEOUS BALLOON2Cleared 510(K)
- K833632ARIES MEDICAL MODEL 7002Cleared 510(K)
- K831397FRENCH INTRA-AORTIC 9.5 BALLOON ON KON2Cleared 510(K)
- K831307PECOR 8.5 FRENCH IAB ON A DATASCOPE2Cleared 510(K)
- K830411MINISCOPE MS-22Cleared 510(K)
- K830410EK COMBI MSG-12Cleared 510(K)
- K823739INTRA-AORTIC BALLOON SYSTEM2Cleared 510(K)
- K823342PERCOR INTRA-AORTIC BALLOON INSERTION2Cleared 510(K)
- K821951DATASCOPE MODEL 83 IABP SYSTEM2Cleared 510(K)
- K823177SMEC BALLOON SYSTEM2Cleared 510(K)
- K820882PECOR, PERCOR-DL, 10.5 FRENCH W/SMEC2Cleared 510(K)
- K821065DATASCOPE 10.5 FRENCH INTRA-AORTIC BAL2Cleared 510(K)
- K813355MODIFICATION OF THE PERCUTAN-BALLOON2Cleared 510(K)
- K820166ADAPTATION OF KANTRON 40 CC. PDLIAB2Cleared 510(K)
- K813182DATASCOPE MODIFIED #82 IABP SYSTEM2Cleared 510(K)
- K813023FUKUDA DENSHI CARDIMAX FK-112Cleared 510(K)
- K811372MODEL 84 TRANSPORT SYSTEM2Cleared 510(K)
- K810297DATASCOPE PERCOR=DL DUAL-LUMEN INTRA2Cleared 510(K)
- K802924KONTRON PERCUTAEOUS DOUBLE-LUMEN2Cleared 510(K)
- K802167PERCOR DATASCOPE INTRA-AORTIC BALLOON2Cleared 510(K)
- K801601DATASCOPE/AVCO CONNECTOR2Cleared 510(K)
- K790755SMEC BALLOON CANNULA2Cleared 510(K)
- K790775INTRA-AORTIC BALLOON, TYPE S2Cleared 510(K)
- K790241INTRA-AORTIC BALLOON-PUMP2Cleared 510(K)
- K781848PUMP, BALLOON MODEL 102Cleared 510(K)
- K780280BALLOON PUMP2Cleared 510(K)
- K770821PUMP, BALLOON, INTRA-AORTIC, TRI-SEGMENT2Cleared 510(K)
- K760695TAMARI-KAPLITT2Cleared 510(K)
- DSRStimulator, Carotid Sinus Nerve3Product Code
- DSSClip, Vascular2Product Code
- DXYImplantable Pacemaker Pulse-Generator3Product Code
- DXZPatch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene2Product Code
- DYEReplacement Heart-Valve3Product Code
- DYFProsthesis, Vascular Graft, Of Less Then 6mm Diameter2Product Code
- KFJMaterials, Repair Or Replacement, Pacemaker3Product Code
- KRDDevice, Vascular, For Promoting Embolization2Product Code
- KREAnalyzer, Pacemaker Generator Function, Indirect2Product Code
- KRFCharger, Pacemaker1Product Code
- KRGProgrammer, Pacemaker3Product Code
- KRHRing, Annuloplasty2Product Code
- LDFElectrode, Pacemaker, Temporary2Product Code
- MABMarker, Cardiopulmonary Bypass (Vein Marker)2Product Code
- MALGraft, Vascular, Synthetic/Biologic Composite2Product Code
- MFXVessel Guard Or Cover, To Facilitate Revision Surgeries2Product Code
- MOPRotator, Prosthetic Heart Valve1Product Code
- MZYGraft, Vascular, Stainless Steel Tunneler2Product Code
- NHWElectrode, Pacing And Cardioversion, Temporary, Epicardial2Product Code
- NKOSystem, Balloon, Intra-Aortic And Control, Reprocessed3Product Code
- OKRVentricular Bypass (Assist) Device3Product Code
- OMHPericardial Patch To Facilitate Revision Surgeries2Product Code
- OMRVessel Guard Or Cover2Product Code
- OTDEndovascular Suturing System2Product Code
- OVJPulse Generator, External Pacemaker, Dual Chamber2Product Code
- PALPulmonic Replacement Heart ValveFProduct Code
- PCKPediatric Ventricular Assist DeviceFProduct Code
- PNJLeadless Pacemaker3Product Code
- PNSShort-Term Intravascular Filter Catheter2Product Code
- PSQIntracardiac Patch Or Pledget, Biologically Derived2Product Code
- PSTAortic Annuloplasty Ring2Product Code
- QABPacing System Analyzer2Product Code
- Subpart E—Cardiovascular Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Cardiovascular Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
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SMEC BALLOON SYSTEM
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K823177
- 510(k) Type
- Traditional
- Applicant
- SMEC, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 12/15/1982
- Days to Decision
- 50 days