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
- P130012MYOPORE SUTURELESS MYOCARDIAL PACING LEADAPPRPMA Approval
- P120017MODEL 5071 LEADAPPRPMA Approval
- K061212BIOTRONIK ENDOCARDIAL PACING LEADS3Cleared 510(K)
- K041809PERMANENT PACING LEAD, MODEL PY23Cleared 510(K)
- K040569PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJU3Cleared 510(K)
- K031274MODEL 5071 MYOCARDIAL PACING LEAD3Cleared 510(K)
- K031210MODEL 4951M MYOCARDIAL UNIPOLAR LEAD3Cleared 510(K)
- K023205ELOX P 45-BP; ELOX P 53-BP; ELOX P 60-BP3Cleared 510(K)
- K024053PERMANENT PACING LEADS, MODELS PHYSIQUE PB AND PJB3Cleared 510(K)
- K023803MODIFICATION TO BIOTRONIK'S STERILIZATION PROCESS3Cleared 510(K)
- P120017Myocardial Pacing Lead3PMA Approval
- P120017Myocardial Pacing Lead3PMA Approval
- P120017Myocardial Pacing Lead3PMA Approval
- P120017Myocardial Pacing Lead3PMA Approval
- P120017Myocardial Pacing Lead3PMA Approval
- P120017Myocardial Pacing Lead3PMA Approval
- P120017Myocardial Pacing Lead3PMA Approval
- P120017Myocardial Pacing Lead3PMA Approval
- P120017Myocardial Pacing Lead3PMA Approval
- P130012Myopore Sutureless Myocardial Pacing Lead3PMA Approval
- P130012Myopore Sutureless Myocardial Pacing Lead3PMA Approval
- P120017Myocardial Packing Lead3PMA Approval
- P120017Myocardial Pacing Lead3PMA Approval
- P130012Myopore Sutureless Myocardial Pacing Lead3PMA Approval
- P120017Myocardial Pacing Lead3PMA Approval
- P120017Myocardial Pacing Lead3PMA Approval
- P120017Myocardial Pacing Lead3PMA Approval
- P130012Myopore Sutureless Myocardial Pacing Lead3PMA Approval
- P120017Myocardial Pacing Lead3PMA Approval
- P120017Myocardial Pacing Lead3PMA Approval
- P120017Myocardial Pacing Lead3PMA Approval
- P120017Myocardial Pacing Lead3PMA Approval
- P120017Myocardial Pacing Lead3PMA Approval
- P120017Myocardial Pacing Lead3PMA Approval
- P130012Myopore Sutureless Myocardial Pacing Lead3PMA Approval
- P120017MYOCARDIAL PACING LEAD3PMA Approval
- P120017MYOCARDIAL PACING LEAD3PMA Approval
- P130012MYOPORE SUTURELESS MYOCARDIAL PACING LEAD3PMA Approval
- P120017Myocardial Pacing Lead3PMA Approval
- P130012MYOPORE SUTURELESS MYOCARDIAL PACING LEAD3PMA Approval
- P120017MYOCARDIAL PACING LEAD3PMA Approval
- P120017MYOCARDIAL PACING LEAD3PMA Approval
- P120017MYOCARDIAL PACING LEAD3PMA Approval
- P120017MYOCARDIAL PACING LEAD3PMA Approval
- P130012MYOPORE SUTURELESS MYOCARDIAL PACING LEAD3PMA Approval
- P120017MODEL 5071 LEAD3PMA Approval
- P960013TENDRILL MODEL 1488T/TC AND 1688T/TC LEADS3PMA Approval
- P960013TENDRIL MODEL 1488T/TC AND 1688T/TC LEADS3PMA Approval
- P960013TENDRIL ST LEAD MODELS 1788T/TC AND 1782 TC3PMA Approval
- P960004THINLINE 2 FINELINE 23PMA Approval
- P950037CYLOS FAMILY OF PULSE GENERATORS3PMA Approval
- P950001SELUTE AND SELUTE PICOTIP3PMA Approval
- P960006FLEXTEND LEADS3PMA Approval
- P960006FLEXTEND FAMILY OF PACING LEADS3PMA Approval
- P960030ISOFLEX S PERMANENT PACING LEAD MODELS PASSIVE PLUS DX3PMA Approval
- P960006FLEXTEND LEADS, MODELS 4086, 4087, AND 40883PMA Approval
- P960030ISOFLEX P LEAD FAMILY MODELS 1644T AND 1648T STEROID ELUTING, PASSIVE FIXATION ENDOCARDIAL PACING LEADS3PMA Approval
- P950001SELUTE FAMILY (INCLUDES SELUTE, SELUTE PICOTIP)3PMA Approval
- P960004FINELINE FAMILY INCLUDES FINELINE, FINELINE II3PMA Approval
- P960006SWEET TIP RX FAMILY INCLUDING SWEET TIP RX, SWEET PICOTIP RX FLEXTEND FAMILY3PMA Approval
- P030005GUIDANT CONTAK RENEWAL TR MODELS H125 AND H1203PMA Approval
- P960004FINELINE, FINELINE II3PMA Approval
- P030005CONTAK RENEWAL TR3PMA Approval
- P950001SELUTE, SELUTE PICOTIP3PMA Approval
- P960006SWEET TIP RX,SWEET PICOTIP RX,FLEXTEND3PMA Approval
- P960004FINELINE,FINELINE II3PMA Approval
- P960006SWEET TIP RX, SWEET PICOTIP RX, FLEXTEND3PMA Approval
- P030005CONTACK RENEWAL TR3PMA Approval
- P950001SELUTE,SELUTE PICOTIP3PMA Approval
- P030005CONTAK RENEWAL TR3PMA Approval
- P030005CONTAK RENEWAL TR (MODEL H120 AND H125)3PMA Approval
- P830061CAPUSRE SP/SENSE SP NOVUS3PMA Approval
- P850089CAPSURE SP NOVUS Z NOVUS3PMA Approval
- P930039MEDTRONIC CAPSUREFIX NOVUS3PMA Approval
- P950001SELUTE,SELUTE PICOTIP3PMA Approval
- P960004FINELINE,FINELINE II3PMA Approval
- P960006SWEET TIP RX,SWEET PICOTIP RX,FLEXTEND3PMA Approval
- P950037PROTOS DR/CLS, PROTOS VR/CLS, AXIOS DR, AXIOS D, AXIOS S, AXIOS SR, AND AXIOS SLR PULSE GENERATORS WITH PROGRAMMER SOFT3PMA Approval
- P930039MEDTRONIC MODEL 5076 LEAD3PMA Approval
- P950037SELOX SR STEROID-ELUTING ACTIVE FIXATION ENDOCARDIAL PACING LEAD MODELS SR45, SR53, SR60 SR 53,SELOX SR 603PMA Approval
- P030005CONTAK RENEWAL TR, MODELS H120, H1253PMA Approval
- P950001SELUTE3PMA Approval
- P960006SWEET TIP RX/SWEET PICOTIP RX/FLEXTEND3PMA Approval
- P960004FINELINE/ THINLINE3PMA Approval
- P930039MEDTRONIC CAPSUREFIX NOVUS MODEL 4076 LEAD3PMA Approval
- P960004FINELINE II PACING LEADS3PMA Approval
- P930039MODEL 5076 CAPSURE FIX NOVUS ELECTRODE3PMA Approval
- P960004THINLINE II STEROX /FINELINE II STEROX ENDOCARDIAL PACING LEADS3PMA Approval
- P960013TENDRIL SDX PERMANENT PACEMAKER LEADS, MODELS 1688T/TC3PMA Approval
- P960006FLEXTEND BIPOLAR, STEROID ELUTING, EXTENDABLE/ RETRACTABLE PACING LEAD3PMA Approval
- P930039MDX SILICONE TUBING3PMA Approval
- P830061MEDTRONIC MODELS CAPSURE SP 4092, CAPSURE SP 4592, CAPSURE SP 4023, CAPSURE SP 4523 AND CAPSURE SENSE 4073; VITATRON...3PMA Approval
- P850089MEDTRONIC MODELS CAPSURE SP 5023M, CAPSURE SP 5524M AND CAPSURE Z 50333PMA Approval
- P950024MEDTRONIC MODEL CAPSUREEPI 4695 AND CAPSUREEPI 49683PMA Approval
- P950037SOLOX VDD PACING LEAD3PMA Approval
- P960030ISOFLEX S PERMANENT PACING LEAD MODELS3PMA Approval
- P930039CAPSURE FIX/NOVUS3PMA Approval
- P850089CAPSURE SP NOVUS/Z NOVUS3PMA Approval
- P830061CAPSURE SP/SENSE/SP NOVUS3PMA Approval
- P960013TENDRIL SDX MODEL 1488T/TC/K3PMA Approval
- P960013TENDRIL DX, MODELS 1388 T/K & TENDRIL SDX MODELS 1488 T/K3PMA Approval
- P960030PASSIVE PLUS DX, MODELS 1336T, 1342T, 1343K, 1345K, 1346T3PMA Approval
- P960006SWEETIP RX/SWEET PICOTIP RX/FLEXTEND3PMA Approval
- P960004THINLINE/FINELINE LEADS AND ACCESSORIES3PMA Approval
- P950001SELUTE LEADS AND ACCESSORIES3PMA Approval
- K023099AROX 45-JBP; AROX 53-JBP; MEROX 45-JBP; MEROX 53-JBP3Cleared 510(K)
- P830061CAPSURE SENSE LEAD MODELS3PMA Approval
- K021217AROX 53-BP; AROX 60-BP; AROX 45-JBP; AROX 53-JBP3Cleared 510(K)
- K010281MEROX BIPOLAR HIGH IMPEDANCE LEAD MODELS: MEX 53/13-BP; 60/15-BP; 45-JBP; 53-JBP3Cleared 510(K)
- P950037PHILOS DR-T PULSE GENERATOR3PMA Approval
- K020669PERMANENT PACING LEAD, MODELS PETITE, PETITE R, J, RJ, PETITE B, RB, JB, RJB3Cleared 510(K)
- P960013TENDRIL DX AND TENDRIL SDX ENDOCARDIAL PACING LEADS3PMA Approval
- P960006FLEXTEND PACING LEADS MODELS 4086, 4087, 4088, AND FIXATIO NTOOL MODEL 66163PMA Approval
- P850089CAPSURE SP MODEL 5024M AND SUREFIX MODEL 5072 LEADSRIES3PMA Approval
- P930039MEDTRONIC CAPSURE SP MODEL 5024M3PMA Approval
- P960004FINELINE II STEROX LEADS3PMA Approval
- P930039CAPSUREFIX FAMILY OF LEADS3PMA Approval
- P850089CAPSURE AND CAPSURE NOVUS FAMILIES OF LEADS/ACCESSORIES3PMA Approval
- P830061CAPSURE FAMILY OF LEADS/ACCESSORIES3PMA Approval
- P950024CAPSURE EPI 4965/49683PMA Approval
- K013339PERMANENT PACING LEAD W/POLARIS COATED TIPS, VARIOUS MODELS3Cleared 510(K)
- P960004THINLINE II/FINELINE II AND THINLINE II/FINELINE II STEROX LEADS3PMA Approval
- P950037AXIOS PULSE GENERATOR FAMILY/B-K05.S.U PROGRAMMER SOFTWARE3PMA Approval
- P950037HOME MONITORING SYSTEM3PMA Approval
- P950037BIOTRONIK INOS2+ CLS PULSE GENERATOR AND B-K05.V.U PROGRAMMER SOFTWARE3PMA Approval
- P950037EDP 30 EXTERNAL DUAL CHAMBER PACEMAKER3PMA Approval
- P830061MEDTRONIC PACING LEADS3PMA Approval
- P950024MEDTRONIC (R) CAPSURE (R) EPI PACING LEAD MODEL 46953PMA Approval
- P930039CAPSUREFIX (R)3PMA Approval
- P850089MEDTRONIC PACING LEADS3PMA Approval
- P850089CAPSURE SP NOVUS LEAD MODEL 55943PMA Approval
- P950037ACTROS AND KAIROS FAMILY OF PULSE GENERATORS WITH LITRONIK BATTERY3PMA Approval
- K003918OSCOR PERMANENT PACING LEAD RZ MODEL SERIES3Cleared 510(K)
- P960004THINLINE II/FINELINE II STEROX PACING LEADS3PMA Approval
- P960004THINLINE II/FINELINE II STEROX PACING LEADS3PMA Approval
- P950037PHILOS PACING SYSTEM3PMA Approval
- K003072PACING LEADS, GUIDE WIRES, AND VARIOUS ACCESSORIES3Cleared 510(K)
- P850089MEDTRONIC(R) CAPSURE(R) NOVUS STEROID ELUTING, BIPOLAR, TRANSVENOUS PACING LEAD MODELS 5054 AND 55543PMA Approval
- P960030TENDRILL PASSIVE PLUS/AU PLUS DX3PMA Approval
- P960013TENDRIL SDX3PMA Approval
- P960004THINLINE II/ FINELINE II3PMA Approval
- P950037PHILOS FAMILY OF PULSE GENERATORS3PMA Approval
- P950037ACTROS SLR PULSE GENERATOR3PMA Approval
- P960004THINLINE II/FINELINE II3PMA Approval
- P960006SWEET TIP RX STEROID ELUTING LEAD3PMA Approval
- P950001ATRIAL J SELUTE PICOTIP STEROID ELUTING LEAD3PMA Approval
- P960013TENDRIL SDX3PMA Approval
- P960030TENDRILL PASSIVE PLUS/AU PLUS DX3PMA Approval
- P950037PHILOS PULSE GENERATORS AND ASSOCIATED PROGRAMMER SOFTWARE.3PMA Approval
- P930039CAPSUREFIX(R)3PMA Approval
- P950001ATRIAL J SELUTE PICOTIP STEROID ELUTING LEAD3PMA Approval
- P950037PHILOS PULSE GENERATOR3PMA Approval
- P950037PHILOS PULSE GENERATOR FAMILY AND SWM1000 B-K-00.0U SOFTWARE CARTRIDGE3PMA Approval
- P950037ACTROS FAMILY OF PULSE GENERATORS3PMA Approval
- P960004THINLINE(TM)II/FINELINE(TM) II LEADS3PMA Approval
- P960004THINLINE II/ FINELINE II PACING LEADS3PMA Approval
- K001413ELOX 45-BP, MODEL 330 132, EFH-27, MODEL 331 549, EXTENSION TOOL, MODEL 331 6683Cleared 510(K)
- P950001IS-1 CONNECTOR TERMINAL OF SELUTE/PICOTIP BIPOLAR LEADS3PMA Approval
- K994240EX 45-BP, MODEL 330 132; EX 53-BP, MODEL 130 018; EX 60-BP, MODEL 330 1333Cleared 510(K)
- K993448STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHAPED TINED PACING LEADS3Cleared 510(K)
- K000763PX 53/15-BP, MODEL 130 050 AND PX 60/15-BP, MODEL 130 0513Cleared 510(K)
- K000029STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHAPED TINED PACING LEADS3Cleared 510(K)
- P960004THINLINE ENDOCARDIAL PACING LEADS3PMA Approval
- P950001SELUTE(R) STEROID-ELUTING LEAD3PMA Approval
- P960006SWEET TIP RX STEROID ELUTING LEAD3PMA Approval
- P960013TENDRIL SDX3PMA Approval
- P960004THINLINE/FINELINE ENDOCARDIAL PACING LEADS3PMA Approval
- P850089CAPSUREZ NOVUS3PMA Approval
- P830061CAPSURE/CAPSURESP/NOVUS3PMA Approval
- P930039CAPSUREFIX/SUREFIX3PMA Approval
- P850089CAPSURE Z/SP3PMA Approval
- P930039SUREFIX3PMA Approval
- P960004THINELINE/FINELINE II ENDOCARDIAL PACING LEADS3PMA Approval
- K993139YP 45/15-BP; YP 53/15-BP; YP 60/15-BP3Cleared 510(K)
- P960004IMPLANTABLE PACEMAKER LEAD3PMA Approval
- P960013TENDRIL/PASSIVE PLUS/AV PLUS DX3PMA Approval
- P960030TENDRIL/PASSIVE PLUS/AV PLUS DX3PMA Approval
- P960004THIN LINE AND FINELINE PACING LEADS3PMA Approval
- P960004THINLINE/FINELINE3PMA Approval
- P950024MEDTRONIC(R) CAPSURE(R) EPI PACING LEAD MODEL 46953PMA Approval
- P960030PASSIVE PLUS DX ENDOCARDIAL, STEROID ELUTING, PASSIVE FIXATION PACING LEADS3PMA Approval
- P850089CAPSURE SP NOVUS MODEL 5092 (AND VITATRON EXCELLENCE SS+ MODEL IML 49B)3PMA Approval
- K990142HT, MODEL HT PB3Cleared 510(K)
- P960004FINELINE3PMA Approval
- K991169SX 53/15-BP, MODEL 124 853, SX 60/15-BP, MODEL 124 8543Cleared 510(K)
- P830061MEDTRONIC CAPSURE SP NOVUS MODEL 4092 VITATRON EXCELLENCE PS+ MODEL IMK 49B TRANVENOUS VENTRICULAR LEAD3PMA Approval
- P850089MEDTRONIC CAPSURE SP NOVUS3PMA Approval
- K990483RETROX RX 45-JBP 124774, 53-JBP 124775, 53-BP 124776, 60-1247773Cleared 510(K)
- P960013LOCATOR STEERABLE STYLET3PMA Approval
- P960006SWEET PICOTIP(TM) RX STEROID ELUTING, POROUS TIP, POSITIVE FIXATION LEAD3PMA Approval
- P950024MEDTRONIC(R) CAPSURE(R) EPI PACING LEAD MODEL 46953PMA Approval
- P960006SWEET TIP RX MODELS 4143/4144/4145/4243/4244/4245 ACTIVE-FIXATION, STEROID ELUTING, ENDOCARDIAL PACING LEADS3PMA Approval
- P850089CAPSURE SP NOVUS3PMA Approval
- P960030PASSIVE PLUS DX STEROID ELUTING, ENDOCARDIAL PACING LEADS3PMA Approval
- P960013TENDRIL DX ENDOCARDIAL PACING LEADS3PMA Approval
- P830061MEDTRONIC CAPSURE SP MODEL 4523M3PMA Approval
- P960030PASSIVE PLUS DX STEROID ELUTING, ENDOCARDIAL PACING LEADS3PMA Approval
- K980869SYNOX SX 53-BP, SX 60-BP, SX 45-JBP, SX 53-JBP , MODELS 120 444, 119 684, 120 438 AND 120 1433Cleared 510(K)
- P930039CAPSURE FIX MODELS 4067,4068, 4568,5068,5568 PACING LEADS3PMA Approval
- P830061MEDTRONIC CAPSURE SP NOVUS MODELS 4092 AND 4592 AND VITATRON EXCELLENCE PS & MODELS IMK49B AND IMK 49JB3PMA Approval
- P950024MEDTRONIC(R) CAPSURE(R) EPI PACING LEAD MODEL 46953PMA Approval
- P830061MEDTRONIC CAPSURE SP NOVUS MODELS 4092 AND 4592 AND VITATRON EXCELLENCE PS & MODELS IMK49B AND IMK 49JB3PMA Approval
- P850089CAPSURE Z NOVUS/CAPSURE SP NOVUS TRANSVENOUS TINED PACING LEADS3PMA Approval
- P930039SUREFIX TM MODEL 5072 LEAD3PMA Approval
- K981083RETROX RX 53-BP, RETROX RX 60-BP, RETROX RX 45-JBP, RETROX RX 53-JBP MODEL NUMBERS 124 396, 124 397, 124 395, 124 0003Cleared 510(K)
- P960013LOCATOR STEERABLE STYLET MODEL 40363PMA Approval
- P930039SUREFIX TM MODEL 5072 LEAD3PMA Approval
- P850089CAPSURE Z NOVUS/CAPSURE SP NOVUS TRANSVENOUS TINED PACING LEADS3PMA Approval
- P950001SELUTE PICOTIP STEROID ELUTING LEAD3PMA Approval
- P960013TENDRIL DX MODEL 1388T & 1388K ENDOCARDIAL PACING LEADS3PMA Approval
- K972500TIR/TIJ AND POLYROX3Cleared 510(K)
- K972814LOCATOR MODEL 40363Cleared 510(K)
- K965106ELC 35-UP MODEL NUMBER 116015 AND ELC 54-UP MODEL NUMBER 1156063Cleared 510(K)
- K972574STELA MODEL UJ45 PACING LEADS3Cleared 510(K)
- P850089CAPSURE(R) AND CAPSURE(R) SP SILICONE PACING LEADS3PMA Approval
- P950001SELUTE STEROID ELUTING ENDOCARDIAL LEAD MODELS 4185 & 42853PMA Approval
- K963738STELA MODEL BJ44 AND BJ45 PACING LEADS3Cleared 510(K)
- K964107OSCOR PERMANENT RETRACTABLE SCREW-IN PACING LEAD MODEL PR3Cleared 510(K)
- K964604BIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEADS, WITH SILICONE RUBBER INSULATION AND PASSIVE FIXATION3Cleared 510(K)
- P850089MEDTRONIC CAPSURE(R) SP MODEL 5024M/5524M PACING LEADS3PMA Approval
- P930039CAPSUREFIX(R) MODEL 4068 PACING LEAD3PMA Approval
- P850089CAPSURE(R) AND CAPSURE(R) SP SILICONE PACING LEADS3PMA Approval
- P930039MEDTRONIC(R) CAPSUREFIX MODEL 4067/4568/5067/5068/5568 PACING LEAD3PMA Approval
- K954610MODEL 430-07 ENDOCARDIAL PACING LEAD3Cleared 510(K)
- P950001SELUTE STEROID ELUTING ENDOCARDIAL LEAD MODELS 4185 & 42853PMA Approval
- P920011MAXIM PFS MODEL 033-3013PMA Approval
- K955122INTERMEDICS MODEL 436-07 BIPOLAR & MODEL 437-07 UNIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEAD3Cleared 510(K)
- K953044UNIPOLAR & BIOPLAR IMPLANTABLE ENDOCARDIAL PACING LEADS, WITH SILICONE RUBBER INSULATION & PASSIVE FIXATION3Cleared 510(K)
- K962036MEDTRONIC MODEL 5058 BIPOLAR, IMPLANTABLE, SCREW-IN, VENTRICULAR/ATRIAL, TRANSVENOUS LEAD3Cleared 510(K)
- K962174BIPLR IM EN PAC LEADS (430-07,432-03,436-02 & 07, 438-05 & 07)3Cleared 510(K)
- K961936MODEL 2188 CORONARY SINUS LEAD.3Cleared 510(K)
- P830061MEDTRONIC(R) POLYURETHANE STEROID-ELUTING LEAD3PMA Approval
- P930039MEDTRONIC(R) SCREW-IN STEROID ELUTING LEAD3PMA Approval
- P850089MEDTRONIC SILICONE STEROID-ELUTING LEAD3PMA Approval
- K961679TRANSVENOUS, PERMANENT TINED TARGET TIP PACING LEADS/TRANSVENOUS, PERMANENT SCREW-IN PACING LEADS3Cleared 510(K)
- K961118MAXIM PF MODELS 033-581/033-5903Cleared 510(K)
- K943657STERILIZATION3Cleared 510(K)
- K955550CARDIFIX EZ BIPOLAR/UNIPOLAR ENDOCARDIAL PACING LEAD3Cleared 510(K)
- K960281IMPLANTABLE PACING LEADS/IMPLANTABLE ACCESSORY/NON-IMPLANTABLE ACCESSORY3Cleared 510(K)
- K954719INTERMEDICS MODEL 430-07 BIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEAD3Cleared 510(K)
- K954714AFP CARDIAC PACING SYSTEM MODEL 283 (MODIFICATION)3Cleared 510(K)
- P800041CARBON TIP CARDIAC PACING LEAD3PMA Approval
- K954551DF-1 TERMINAL CAP3Cleared 510(K)
- P850089CAPSURE Z MODELS 5034/5534/5033 PACING LEADS3PMA Approval
- K954085MODELS 5866-45 AND 5866-46 SIZING SLEEVE3Cleared 510(K)
- P830061MEDTRONIC(R) CAPSURE(R) SP TRANSVENOUS PACING LEAD3PMA Approval
- P850089CAPSURE(R) AND CAPSURE(R)SP LEADS3PMA Approval
- K951858TRANSVENOUS, PERMANENT TINED TARGET TIP PACING LEADS3Cleared 510(K)
- K952206PASSIVE PLUS PACING LEADS WITH TITANIUM NITRIDE COATING3Cleared 510(K)
- K951950PASSIVE PLUS PACING LEADS WITH TITANIUM NITRIDE COATING3Cleared 510(K)
- K951087TENDRIL, UNIPOLAR ENDOCARDIAL SCREW-IN LEAD3Cleared 510(K)
- P850089CAPSURE(R) AND CAPSURE(R)SP LEADS3PMA Approval
- P830061MEDTRONIC(R) CAPSURE(R) SP TRANSVENOUS PACING LEAD3PMA Approval
- P850089CAPSURE(R) AND CAPSURE(R)SP LEADS3PMA Approval
- P830061MEDTRONIC(R) CAPSURE(R) SP TRANSVENOUS PACING LEAD3PMA Approval
- P850089CAPSURE(R) AND CAPSURE(R)SP LEADS3PMA Approval
- K940703MEDTRONIC MODEL 4558M3Cleared 510(K)
- P800041CARBON TIP CARDIAC PACING LEAD3PMA Approval
- K942440AFP CARDIAC PACING SYSTEM MODEL 2833Cleared 510(K)
- K925038PACING LEAD MODEL 1188T3Cleared 510(K)
- K932892PASSIVE PLUS ENDOCARDIAL PACING LEADS VAR. MODELS3Cleared 510(K)
- K930876SILICONE BIPOLAR LEAD MODELS 1136T, 1142T &1146T3Cleared 510(K)
- P800041CARBON TIPPED LEAD MODELS 1085S,1085M,& 1085K3PMA Approval
- K933055MEDTRONIS(R) PACING LEADS AND LEAD ADAPTORS, MODIF3Cleared 510(K)
- K933731MEDTRONIC MODEL 5028 TARGET TIP, BIPOLAR, IMPLANTABLE, TINED, VENTRICULAR, TRANSVENOUS LEAD3Cleared 510(K)
- P830061MEDTRONIC(R) MODEL 4003M,4503M,4504M,& 4523 PACING3PMA Approval
- P830061CAPSURE(R) AND CAPSURE(R) SP PACING LEADS3PMA Approval
- P850089CAPSURE(R) AND CAPSURE(R)SP LEADS3PMA Approval
- P850089CAPSURE(R) AND CAPSURE(R)SP LEADS3PMA Approval
- P830061CAPSURE(R) AND CAPSURE(R) SP PACING LEADS3PMA Approval
- K932172MEDTRONIC MODELS 4057M,4058M,4557M, PACING LEADS3Cleared 510(K)
- P850089CAPSURE(R) AND CAPSURE(R)SP LEADS3PMA Approval
- K920662VASCOTWIST 9/603Cleared 510(K)
- K931411MEDTRONIC MODEL 4081,4581,4582 TARGET TIP PACING L3Cleared 510(K)
- K913831VASCO TIP/VASCOFLANGE3Cleared 510(K)
- K914121VASCOSCREW 6/60 AND VASCOSCREW 8/603Cleared 510(K)
- K932254MAXIMA FILTERED HARDSHELL RESERVOIR3Cleared 510(K)
- K925099POSSIS MEDICAL MYOPORE BIPOLAR SUTURELESS MYCARDIA3Cleared 510(K)
- K925347MODEL 1148T TRANSVENOUS, SCREW-IN LEAD3Cleared 510(K)
- K922042CARDIFIX ENDOCARDIAL PACING LEAD3Cleared 510(K)
- K922972MODELS 438-05 AND 435-05 IMPLANTABLE PACING LEAD3Cleared 510(K)
- K920822CARDIOVASCULAR PERMANENT PACEMAKER ELECTRODE3Cleared 510(K)
- P850089CPI MODEL4262 PACE LEAD ,MODIFY TECH MANUAL3PMA Approval
- K915736MEDTRONIC MODELS 5069 AND 5071 MYOCARDIAL PACING3Cleared 510(K)
- P800041CARBON TIPPED LEAD ALT.PROD.TRAYS3PMA Approval
- K915188MODEL P IN-LINE BIPOLAR ENDOCARDIAL TINED LEAD3Cleared 510(K)
- K914489NEW EXTRUSION VENDOR FOR POLYURETHANE TUBING3Cleared 510(K)
- K921124MODELS 6917T, 6917AT & 4951M EPICARDIAL PACE LEADS3Cleared 510(K)
- P850089CPI DEXATIP(TM) MODEL 4262 TRANSVENOUS PACING LEAD3PMA Approval
- P850089CAPSURE(R) SP MODEL 5024M TRANSVENOUS PACING LEAD3PMA Approval
- P850089MEDTRONIC(R) CAPSURE(R)&CAPSURE(R) SP PACING LEADS3PMA Approval
- P830061CAPSURE(R) AND CAPSURE(R) SP PACING LEADS3PMA Approval
- K912464PERMANENT CARDIAC PACING LEADS AND ADAPTORS3Cleared 510(K)
- K912867OSCOR MEDICAL CORP PERMANENT PACING LEAD3Cleared 510(K)
- K915008PERMANENT PACING PAD, MODIFICATION3Cleared 510(K)
- K915007PERMANENT PACING LEADS, MODIFICATION3Cleared 510(K)
- P850089CAPSURE(R) MODEL 5023M,5024M PACING LEADS3PMA Approval
- P850089CAPSURE(R) PACING LEADS3PMA Approval
- K913288MEDTRONIC UNIPOLAR, POLY PAC LEAD-BARR COAT COILS3Cleared 510(K)
- K913203IMPLANT PACING LEAD TINED #3390, MODIFICATION3Cleared 510(K)
- K913393IMPLANT PACING LEAD, RETRACTABLE, MODIFICATION3Cleared 510(K)
- K913158MODIFIED OSCOR PY PACING LEADS/MODIFICATION3Cleared 510(K)
- K913202IMPLANT PACING LEAD, TINED #3262, MODIFICATION3Cleared 510(K)
- K913204MODEL KY PACEMAKER LEAD-VARIOUS, MODIFICATION3Cleared 510(K)
- K913205OSCOR MEDICAL FIX SCREW PAC LEAD/PEEL CATH, MODIF3Cleared 510(K)
- K913201PRODUCTS IMPLANT PACING LEAD, TINED, MODIFICATION3Cleared 510(K)
- K912235MODELS 432-03 & 433-03 IMPLANT ENDOCARD PAC LEAD3Cleared 510(K)
- K911273100 CM PERMANENT PACING LEAD MODELS3Cleared 510(K)
- K910924ENDOCARDIAL LEADS-MOD. TO THE POLYVINYLPYRROLIDONE3Cleared 510(K)
- K910609PERMANENT IMPLANTABLE JP ENDOCARDIAL LEADS W/TIP3Cleared 510(K)
- P830061CAPSURE(R)SP MODELS 4024/4524 PACING LEADS3PMA Approval
- K910528BIPOLAR SUTURELESS MYOCARDIAL PACING LEADS3Cleared 510(K)
- P830061MEDTRONIC{R} CAP SURE{TM} MODEL 4003/4503 PACING3PMA Approval
- K910608PERMANENT IMPLANTABLE FH ENDOCARDIAL LEADS W/TIP3Cleared 510(K)
- K905300PERMANENT PACING LEAD3Cleared 510(K)
- K905182OSCOR MEDICAL CORP. PERMANENT PACING PAD3Cleared 510(K)
- K903948INTERMEDICS MODEL 431-11 IMPLANT ENDOCARD PAC LEAD3Cleared 510(K)
- P830061CAPSURE(R)SP PACING LEADS3PMA Approval
- K902672INTERMEDICS 430-07 BIPOL IMPLANT ENDOCARD PAC LEAD3Cleared 510(K)
- K904255FOCUS T41,T41F,T43, T43F,T44F3Cleared 510(K)
- K904741LASERDISH POLY UNIPOLAR VENTRI LEAD W/TRAIL TINES3Cleared 510(K)
- P800041CARBON TIPPED LEAD MODELS 1085S,1085M,& 1085K3PMA Approval
- P850089CAPSURE(R) PACING LEADS3PMA Approval
- P830061CAPSURE(R)SP PACING LEADS3PMA Approval
- P800041CARBON TIPPED LEAD MODELS 1085S,1085M,& 1085K3PMA Approval
- K903221LASERDISH SILICONE VENTRICULAR LEAD W/TRAILING TIN3Cleared 510(K)
- K903927LABEL CHANGE UNIPOLAR ENDOCARDIAL LEAD, DJP 45-UP3Cleared 510(K)
- K903928LABEL CHANGE UNIPOLAR ENDOCARDIAL LEAD DJP 53-UP3Cleared 510(K)
- K903929LABEL CHANGE UNIPOLAR ENDOCARDIAL LEAD, DJP 60-UP3Cleared 510(K)
- P830061CAPSURE(R)SP PACING LEADS3PMA Approval
- P850089CAPSURE(R) PACING LEADS3PMA Approval
- P850089MODEL 5024 TRANSVENOUS PACING LEAD3PMA Approval
- K902002MODELS 5069/5071 MYOCARDIAL PACING LEADS3Cleared 510(K)
- P850089MODEL 5023M UNIPOLAR PACING LEAD3PMA Approval
- K900645LASERDISH POLYURETHANE VENTRICULAR LEAD W/TRAILING3Cleared 510(K)
- K896824BIOTRONIK'S PS-ENDOCARDIAL LEADS3Cleared 510(K)
- K902147ENDOCARDIAL SCREW-IN LEAD MODEL 1028T3Cleared 510(K)
- K896742FOCUS J81F, J83F, J41F, J43F PACING LEADS3Cleared 510(K)
- K901402VS-1 LEAD EXT. 033-302, 4.75MM 033-260, 033-4583Cleared 510(K)
- K901709DNP 60-B UNIPOLAR ENDOCARDIAL LEAD3Cleared 510(K)
- K900984MODIFIED UNIPOLAR IMPLANT. PACING LEADS W/IS-13Cleared 510(K)
- K900550FAST-PASS ACE MODELS 1212T/1222T/1216T/1226T3Cleared 510(K)
- P830061MODELS 4004/4504 PACING LEADS3PMA Approval
- K896313MEDTRONIC IMPLANTABLE PACING LEADS W/IS-1 CONN.3Cleared 510(K)
- K895136PERMANENT AND TEMP. PACEMAKER ELECTRODE & LEAD ADA3Cleared 510(K)
- K897067MODIFIED J-STIFFENER WIRE MATERIAL IN LEAD LINES3Cleared 510(K)
- K892528FIVE-YEAR STERILE PACKAGING SHELF LIFE3Cleared 510(K)
- K896443MYOPORE(TM) UNIPOLAR MODELS 1117 & 1118 PACE LEADS3Cleared 510(K)
- K895447ENDOCARDIAL SCREW-IN LEAD MODEL 1020T3Cleared 510(K)
- P850089MEDTRONIC{R} CAPSURE{TM} MODEL 5052/55253PMA Approval
- K893041NEW ADHESIVE, PELLETHAN ON POLYURETHANE LEADS-MODI3Cleared 510(K)
- K894040IMPLANTABLE PACING LEADS W/IS-1 CONN., UNIPOLAR3Cleared 510(K)
- K893763MODELS 1113 AND 1114 PACEMAKER LEADS3Cleared 510(K)
- K885175MYOPORE(TM) UNIPOLAR SUTURELESS MYOCARDIAL LEADS3Cleared 510(K)
- P830061MEDTRONIC{R} CAP SURE{TM} MODEL 4003/4503 PACING3PMA Approval
- K890018PACEMAKER LEAD ADAPTER3Cleared 510(K)
- P800041ENDOCARDIAL PACEMAKER LEAD W/CARBON TIP3PMA Approval
- K891905CARDIOVASCULAR PERMANENT PACEMAKER ELECTRODE3Cleared 510(K)
- K890644MEDTRONIC MODEL 5866-45 SIZING SLEEVE3Cleared 510(K)
- P830061MEDTRONIC{R} CAP SURE{TM} MODEL 4003/4503 PACING3PMA Approval
- P850089MEDTRONIC{R} CAPSURE{TM} MODEL 5052/55253PMA Approval
- K890527ALTERNATE PACKAGING CONFIGURATION FOR PACING LEADS3Cleared 510(K)
- P850089MEDTRONIC{R} CAPSURE{TM} MODEL 5052/55253PMA Approval
- K884697HEPARIN BONDING FOR CATHETERS3Cleared 510(K)
- K890411MODELS 432-03 & 433-03 IMPLANTABLE PACING LEADS3Cleared 510(K)
- K890412MODELS 430-07 & 431-07 IMPLANTABLE PACING LEADS3Cleared 510(K)
- K890547SIEMENS ELEMA MODELS 4025 AND 4026 ADAPTERS3Cleared 510(K)
- K884811ACCUFIX AND LASERDISH BIPOLAR VS-1 LEADS3Cleared 510(K)
- K885240MODIFIED ANCOR & HI-FLEX UNIPOLAR ACTIVE FIX. LEAD3Cleared 510(K)
- P830061MEDTRONIC{R} CAP SURE{TM} MODEL 4003/4503 PACING3PMA Approval
- P830061MEDTRONIC{R} CAP SURE{TM} MODEL 4003/4503 PACING3PMA Approval
- P850089MEDTRONIC{R} CAPSURE{TM} MODEL 5052/55253PMA Approval
- K890350VS-1 SILICONE IMPLANT LEADS (NEW SERIAL # TUBE)3Cleared 510(K)
- K890045MODEL 6208,6209,6210,6211,6212,6214 (PLI'S)3Cleared 510(K)
- K883743MEDTRONIC MODEL 4058 PACING LEAD3Cleared 510(K)
- K884278IMPLANTABLE ELECTRODE LEADS 033-400,402 AND 4363Cleared 510(K)
- K884394PACING LEADS FOCUS T81,T81F,T82F,T83,T83F,T84F3Cleared 510(K)
- K884005ENDOCARDIAL PACING LEADS-ANCHORING SLEEVE MODIFIED3Cleared 510(K)
- K883070ENCOR UNIPOLAR VS-1 LEADS3Cleared 510(K)
- P850089MEDTRONIC{R} CAPSURE{TM} MODEL 5052/55253PMA Approval
- K882462PERMANENT PACING LEAD MODEL RXBJ SERIES3Cleared 510(K)
- K882345PERMANENT PACING LEADS PYBJ SERIES3Cleared 510(K)
- K873772CHANGES TO ENCOR PERVENOUS J-ATRIAL LEADS3Cleared 510(K)
- K884024POLYSAFE(TM) IMPLANTABLE PACING LEAD3Cleared 510(K)
- K883265MODEL 329-701 BIPOLAR ACTIVE-FIXATION LEAD3Cleared 510(K)
- K881810MEDTRONIC MODEL 4951P3Cleared 510(K)
- K883015POLYSAFE IMPLANT. PACING LEADS W/TRABECULOK TIP3Cleared 510(K)
- K883016POLYSAFE IMPLANT. PACING LEADS W/TINED FIXA. TIP3Cleared 510(K)
- K883602BIOPORE VS.1 ENDOCARDIAL INTER IMPLANT PACING LEAD3Cleared 510(K)
- K883203MODEL 5866-34A PACEMAKER LEAD ADAPTOR3Cleared 510(K)
- K882452MEDTRONIC MODELS 4057/4557 ENDOCARDIAL PACING LEAD3Cleared 510(K)
- K874366ENCOR BIPOLAR ACT/FIXA LEAD W/POR SUR ELE #329-2013Cleared 510(K)
- K874664IMPLANTABLE ELECTRODE LEAD, MODEL 030-4463Cleared 510(K)
- K881712MEDTRONIC MODEL 5866-36 LEAD ADAPTOR KIT3Cleared 510(K)
- K875178MODEL 435-04 CARDIFIX SIDE HOOK IMPLANT. PACE LEAD3Cleared 510(K)
- K875100MODEL 438-03 CARDIFIX SIDE HOOK IMPLANT. PACE LEAD3Cleared 510(K)
- K872126MODEL 438-02 CARDIFIX SIDE HOOK IMPLANT. PACE LEAD3Cleared 510(K)
- P850089MEDTRONIC{R} CAPSURE{TM} MODEL 5052/55253PMA Approval
- K880551MODEL 439-07 AND 439-09 LIFELINE MYOCARDIAL LEAD3Cleared 510(K)
- P830061MEDTRONIC{R} CAP SURE{TM} MODEL 4003/4503 PACING3PMA Approval
- P850089MEDTRONIC{R} CAPSURE{TM} MODEL 5052/55253PMA Approval
- K875199NP BIPOLAR ENDOCARDIAL LEAD W/VS-1 CONNECTOR3Cleared 510(K)
- K872971PERMANENT MYOCARDIAL LEADS MP SERIES3Cleared 510(K)
- K874205ENDOCARDIAL SCREW-IN LEAD, MODEL 1018T3Cleared 510(K)
- K873962MEDTRONIC MODEL 4016A ENDOCARDIAL PACING LEAD3Cleared 510(K)
- K874183ACTIFIX (R) BIPOLAR ENDOCARDIAL SCREW-IN LEAD3Cleared 510(K)
- K874792MODEL 5013 TRANSVENOUS VENTRICULAR PACING LEAD3Cleared 510(K)
- K874743PACING LEADS MODEL 3262VU/VB, 3362VU/VB, 3380/33903Cleared 510(K)
- K874531POLYFLEX(R) EPICARDIAL 439-04 IMPLANT PACING LEAD3Cleared 510(K)
- K874930MODEL 366-12 ADAPTAID(TM) STEP-DOWN ADAPTER3Cleared 510(K)
- K874167MEDTRONIC PERMANENT LEAD INTRODUCER3Cleared 510(K)
- K873921MODEL 366-30 ADAPTAID(TM) ADAPTER SLEEVE3Cleared 510(K)
- P850089MEDTRONIC{R} CAPSURE{TM} MODEL 5052/55253PMA Approval
- K870885MEDTRONIC MODEL 5513 ENDOCARDIAL PACING LEAD3Cleared 510(K)
- K873931MODIFIED MODELS 1025M & 1026T PACING LEAD3Cleared 510(K)
- K872731PICF 0860/PSCF 0860/PSC 0860/PIAF 0860/PSAF 08603Cleared 510(K)
- K865098SLIMLINE UNIPOLAR ENDOCARDIAL PACING LEAD, 030-4383Cleared 510(K)
- P830061MEDTRONIC{R} CAP SURE{TM} MODEL 4003/4503 PACING3PMA Approval
- P800041ENDOCARDIAL PACEMAKER LEAD W/CARBON TIP3PMA Approval
- K870016ARTERIAL BLOOD GASSING MONITORING SYSTEM (ABG)3Cleared 510(K)
- K871580IMPLANTABLE PACING LEAD MODELS 487-06 TO 430-013Cleared 510(K)
- K871625MODEL 366-12 ADAPTAID (TM) STEP-DOWN ADAPTER3Cleared 510(K)
- K870357ELECTRODE, PACEMAKER, PERMANENT & TEMPORARY3Cleared 510(K)
- K864618IMPLANTABLE ELECTRODE LEAD, MODEL 030-4393Cleared 510(K)
- K871333IMPLANTABLE TINED, TRANS. PACING LEAD/REVIS. LABEL3Cleared 510(K)
- P830061MEDTRONIC{R} CAP SURE{TM} MODEL 4003/4503 PACING3PMA Approval
- K870948MODEL 435-03 SIDE HOOK IMPLANTABLE PACING LEAD3Cleared 510(K)
- K870610RESUBMISSION OF MODEL 030-437 IMPLANT. ELECTRODE3Cleared 510(K)
- K870824ADDITIONAL CARDIAC PACING LEADS #1020 THROUGH 10353Cleared 510(K)
- K870034MODEL PY...U UNIPOLAR & BIPOLAR PACING LEAD3Cleared 510(K)
- K864326MODEL 366-13 ADAPTAID STEP DOWN ADAPTER3Cleared 510(K)
- K864856MODEL 5866-24 PACEMAKER LEAD ADAPTOR3Cleared 510(K)
- K864738MODEL 366-14 INTERMEDICS LEAD CONNECTOR CAP3Cleared 510(K)
- K864640ANCOR PERVENOUS ACTIVE FIXATION UNIPOLAR LEAD3Cleared 510(K)
- K864601CCS POLYSAFE(TM) ENDOCARDIAL PACING LEAD3Cleared 510(K)
- K864153PACE IMPLANT. LEAD/TINED/ATRIAL/J/MODEL 32903Cleared 510(K)
- K863536MEDTRONIC MODEL 50133Cleared 510(K)
- K862051MODEL 436-01 BIOPORE IMPLANTABLE PACING LEAD3Cleared 510(K)
- K864564MODEL 486-05 POLYFLEX(R) IMPLANTABLE PACING LEAD3Cleared 510(K)
- K864428MODEL 366-23 ADAPTAID(TM) STEP-DOWN ADAPTER3Cleared 510(K)
- K864098TELECTRONICS SREW-IN/SLIM LINE PACING LEADS3Cleared 510(K)
- K863921DAIG TYPE O4 VS-1 CONNECTOR3Cleared 510(K)
- P850089MODEL 5525 TRANSVENOUS ATRAIL & MODEL 5025 VENTRIC3PMA Approval
- K864287MODEL 430-05 POLYFLEX IMPLANTABLE PACING LEAD3Cleared 510(K)
- K864002MODEL 431-06 POLYFLEX IMPLANTABLE PACING LEAD3Cleared 510(K)
- K864048MODEL 366-27 ADAPTAID(TM) STEP-DOWN ADAPTER3Cleared 510(K)
- K864047MODEL 366-28 ADAPTAID(TM) STEP-DOWN ADAPTER3Cleared 510(K)
- K863781MODEL 493-08 POLYFLEX ENDOCARDIAL LEAD3Cleared 510(K)
- P830061MEDTRONIC{R} CAP SURE{TM} MODEL 4003/4503 PACING3PMA Approval
- K8629663.2MM UNIPOLAR & BIPOLAR LEAD CONNECTORS (VS-1)3Cleared 510(K)
- P850089MEDTRONIC{R} CAPSURE{TM} MODEL 5052/55253PMA Approval
- P830061STEROID TIP(TM) MODEL 4503&4003 TRANSVENOUS PACING3PMA Approval
- P850089MODEL 5525 TRANSVENOUS ATRAIL & MODEL 5025 VENTRIC3PMA Approval
- K863480BIOTRONIK PERMANENT PACEMAKER ELECTRODE3Cleared 510(K)
- K862054MODEL 430-01 BIOPORE IMPLANTABLE PACING LEAD3Cleared 510(K)
- K862053MODEL 432-01 BIOPORE IMPLANTABLE PACING LEAD3Cleared 510(K)
- P800041ENDOCARDIAL PACEMAKER LEAD W/CARBON TIP3PMA Approval
- K861493OSCOR MEDICAL FIX SCREW PACING LEAD/PEELABLE CATH3Cleared 510(K)
- K862330MODIFIED OSCOR PY PACING LEADS3Cleared 510(K)
- K851064CORDIS HI-FLEX PERVENOUS ACTIVE FIXATION UNIPOLAR3Cleared 510(K)
- K832422CORDIS ANCOR ACTIVE FIXATION LEAD3Cleared 510(K)
- K861767IMPLANTABLE ELECTRODE LEAD, MODEL 030-4363Cleared 510(K)
- K862443MEDTRONIC TEMPORARY AND IMPLANTABLE PACING LEADS3Cleared 510(K)
- K862258MODEL 437-01 BIOPORE IMPLANTABLE PACING LEAD3Cleared 510(K)
- K862259MODEL 433-01 BIOPORE IMPLANTABLE PACING LEAD3Cleared 510(K)
- K862257MODEL 431-02 BIOPORE IMPLANTABLE PACING LEAD3Cleared 510(K)
- K862052MODEL 438-01 CARDIFIX IMPLANTABLE PACING LEAD3Cleared 510(K)
- K862276MODEL 435-02 CARDIFIX IMPLANTABLE PACING LEAD3Cleared 510(K)
- K860846CORDIS HI-FLEX PERVENOUS BIPOLAR LEAD3Cleared 510(K)
- K854963S80 IMPLANTABLE CARDIAC PACING LEAD3Cleared 510(K)
- K860548MODEL 492-02 ENDOCARDIAL PACING LEAD3Cleared 510(K)
- K860547MODEL 486-02 ENDOCARDIAL PACING LEAD3Cleared 510(K)
- K861481ENDOCARDIAL CARBON-TIP LEAD3Cleared 510(K)
- K861464LEAD BODY CHANGES TO HI PERFORM & FAST-PASS LEADS3Cleared 510(K)
- K861440LEADS UTILIZ VOLUN STAND #1 3.2 MM UNI/BIOPOLAR CO3Cleared 510(K)
- K853567DJP UNIPOLAR3Cleared 510(K)
- K853566DJ UNIPOLAR3Cleared 510(K)
- K861176MODEL 366-20 ADAPTAID STEP-DOWN ADAPTER3Cleared 510(K)
- K861110MODEL 366-10 ADAPTAID STEP-DOWN ADAPTER3Cleared 510(K)
- K860986MODEL 366-09 ADAPTAID ADAPTER SLEEVE3Cleared 510(K)
- K860985MODEL 366-19 ADAPTAID ADAPTER SLEEVE3Cleared 510(K)
- K854918MODEL 431-01 BIOPORE IMPLANTABLE PACING LEAD3Cleared 510(K)
- K854917MODEL 435-01 CARDIFIX IMPLANTABLE PACING LEAD3Cleared 510(K)
- K854128OSCOR MEDICAL UNIPOLAR PERMANENT PACING LEAD-CONNE3Cleared 510(K)
- P800041ENDOCARDIAL PACEMAKER LEAD W/CARBON TIP3PMA Approval
- K854142STYLET INTRODUCER FUNNEL3Cleared 510(K)
- K853568DNR UNIPOLAR3Cleared 510(K)
- K854582MOD TARGET/TIPS # 4011,4012,4511,4512,6912,40163Cleared 510(K)
- K853446POLYSAFE CCS TRIFIX ENDOCARDIAL PACING LEAD SV-1073Cleared 510(K)
- K853747NAVIGATOR3Cleared 510(K)
- K854069POLYFLEX 483-09 ENDOCARDIAL IMPLANTABLE PACINGLEAD3Cleared 510(K)
- K854405PACESETTER SYSTEMS ENDOCARDIAL SMALL FIN LEAD3Cleared 510(K)
- K854220PACESETTER SYSEMS ENDOCARDIAL TRI-FIX LEAD3Cleared 510(K)
- K854071POLYFLEX 493-07 ENDOCARDIAL IMPLANTABLE PAC-LEAD3Cleared 510(K)
- K853850EXPLORER3Cleared 510(K)
- K853521POLYFLEX IMPLANTABLE PACING LEAD-476-073Cleared 510(K)
- K853517LIFELINE ENDOCARDIAL UNIPOLAR LEAD 483-083Cleared 510(K)
- K853294CCS MODEL BV-114 IMPLANTABLE ENDOCARDIAL BIPOLARPA3Cleared 510(K)
- K853398MEDTRONIC MODEL 50623Cleared 510(K)
- K852710IMPLANT ELECT LEAD MOD 30-404 USING POLYU 90 A3Cleared 510(K)
- K853914PACESETTER SYS FAST PASS ENDOCARDIAL LEAD 856 INLI3Cleared 510(K)
- K853518LIFELINE ENDOCARDIAL BIPOLAR LEAD 476-063Cleared 510(K)
- K853519LIFELINE ENDOCARDIAL BIPOLAR LEAD 484-033Cleared 510(K)
- K853520LIFELINE ENDOCARDIAL UNIPOLAR 487-06 TLE LEAD3Cleared 510(K)
- K853411MODEL 486-03 POLY FLEX IMPLANTABLE PACING LEAD3Cleared 510(K)
- K852708IMPLANT ELECT LEAD, MOD 030-405 USING POLYU 90 A3Cleared 510(K)
- K853223SLIMLINE UNIPOLAR ENDOCARDIAL PACING LEAD, #30-4073Cleared 510(K)
- K853222SLIMLINE UNIPOLAR ENDOCARDIAL PACING LEAD, #30-4023Cleared 510(K)
- K853221SLIMLINE UNIPOLAR ENDOCARDIAL PACING LEAD,#30-4013Cleared 510(K)
- K852709IMPLANT ELECT LEAD, MOD 30-403 USING POLYU 90 A3Cleared 510(K)
- K852446ENDOCARDIAL SCREW-IN LEAD WITH PLATINUM POROUS TIP3Cleared 510(K)
- K852972IMPLANTABLE ELECTRODE LEAD, MODEL 030-4003Cleared 510(K)
- K852119TEMPORARY PACEMAKER GROUND WIRE3Cleared 510(K)
- K851731ELA MEDICAL PACING LEADS PMC 860 PMCF 860 PBCF8603Cleared 510(K)
- K852915SLIM VENT UNIPO PACING LEAD USING POLYU 90A,30-2813Cleared 510(K)
- K851461IMPLANTABLE ELECTRODE ADAPTOR ASSEMBLE3Cleared 510(K)
- K850623OSCOR MEDICAL IMPLANTABLE PACING LEAD, RETRACTABLE3Cleared 510(K)
- P800041ENDOCARDIAL PACEMAKER LEAD W/CARBON TIP3PMA Approval
- K851296IMPLANTABLE ELECTRODE LEAD 030-269 USING POLYURETH3Cleared 510(K)
- K851295IMPLANTABLE ELECTRODE LEAD 030-271 USING POLYURETH3Cleared 510(K)
- K851297IMPLANTABLE ELECTRODE LEAD, 030-270 USING POLYURET3Cleared 510(K)
- K851294IMPLANTABLE ELECTRODE LEAD 030-272 USING POLYURETH3Cleared 510(K)
- K850065ELECATH TORKFLOAT PACING PROBE3Cleared 510(K)
- K820267INTERMEDICS POLYFLEX PACING LEAD #480-013Cleared 510(K)
- K813136MODEL 492-01 PACEMAKER LEAD3Cleared 510(K)
- K813135MODEL 486-01 PACEMAKER LEAD3Cleared 510(K)
- K802294POLY FLEX IMPLANTABLE PACING LEAD3Cleared 510(K)
- K844269MODEL 483-02 PACING LEAD3Cleared 510(K)
- K844259MODEL 486-01 PACING LEAD3Cleared 510(K)
- K844260MODEL 476-03 PACING LEAD3Cleared 510(K)
- K844261MODEL 490-01 PACING LEAD3Cleared 510(K)
- K844262MODEL 483-01 PACING LEAD3Cleared 510(K)
- K844263MODEL 493-01 PACING LEAD3Cleared 510(K)
- K844264MODEL 493-03 PACING LEAD3Cleared 510(K)
- K844265MODEL 495-01 PACING LEAD3Cleared 510(K)
- K844266MODEL 492-01 PACING LEAD3Cleared 510(K)
- K844267MODEL 483-01 PACING LEAD3Cleared 510(K)
- K844268MODEL 483-03 PACING LEAD3Cleared 510(K)
- K844270MODEL 480-01 PACING LEAD3Cleared 510(K)
- K844271MODEL 479-01 PACING LEAD3Cleared 510(K)
- K844272MODEL 473-03 PACING LEAD3Cleared 510(K)
- K844970CORDIS ENCOR PERVENOUS ATRIAL & VENTRICULAR LEADS3Cleared 510(K)
- K842031TRANSVENOUS TINED VENTRICULAR/ATRIAL3Cleared 510(K)
- K842032MODELS 4012/4512 TRANSVENOUS TINED-3Cleared 510(K)
- K844959MEDTRONIC 6304, 6305,6306,6506 & 6506W. TEMP.PACIN3Cleared 510(K)
- K843707MEDTRONIC 6957J3Cleared 510(K)
- K844752TRANSVENOUS BALLOON TIPPED(FLOW DIRECTED) TEMP. PA3Cleared 510(K)
- K843706MEDTRONIC 69573Cleared 510(K)
- K811259CORDIS ENCOR ATRIAL LEAD3Cleared 510(K)
- K843393LIFELINE TLE 476-043Cleared 510(K)
- K843394LIFELINE TLE 484-023Cleared 510(K)
- K840668ELECTRODE PACEMAKER, PERM & TEMP3Cleared 510(K)
- K834431PACING ELECTRODE3Cleared 510(K)
- K834342CCS MODEL AV-102 IMPLANTABLE A-V DATA3Cleared 510(K)
- K834533ELECTRODE LEAD CONSTRUCTION3Cleared 510(K)
- K833824ENDOCARDIAL SCREW-IN LEAD 859 & 8613Cleared 510(K)
- K833099BIOTRONIK N, BIPOLAR PEB-60/4-N3Cleared 510(K)
- K833106BIOTRONIK DFH UNIPOLAR PE-60/4-DFH3Cleared 510(K)
- K832987PERMANTHANE #866 BIPOLAR COAXIAL3Cleared 510(K)
- K831997IMPLANTABLE ENDOCARDIAL PACING LEADS3Cleared 510(K)
- K833108BIOTRONIK I-UNIPOLAR PE-60/2-133Cleared 510(K)
- K833098BIOTRONIK DN UNIPOLAR PE-60/4-DN &3Cleared 510(K)
- K833101BIOTRONIK DYC, UNIPOLAR PE-60/4-DYC3Cleared 510(K)
- K833104BIOTRONIK D2K UNIPOLAR PE-60/43Cleared 510(K)
- P800041ENDOCARDIAL PACEMAKER LEAD W/CARBON TIP3PMA Approval
- K832409LIFELINE PACING LEADS #471-07 &093Cleared 510(K)
- K832245UNIPOLAR-E ENDOCARDIAL TINED LEAD3Cleared 510(K)
- K832255MODEL F UNIPOLAR ENDOCARDIAL LEAD-3Cleared 510(K)
- K832110ELECTRODE LEADS 030-267 & 030-2683Cleared 510(K)
- K832099MEDTRONIC MODELS 4012 & 45123Cleared 510(K)
- K831767IMPLANTABLE CARDIAC PACING LEADS3Cleared 510(K)
- K831529CCS MODEL SJ-103 IMPLANTABLE ATRIAL3Cleared 510(K)
- K831435VENTRICULAR PACING LEADS MODELS 865/8673Cleared 510(K)
- K831436UNIPOLAR ATRIAL J PACING LEAD MODEL 8693Cleared 510(K)
- K831303TELECTRONICS #030-253 BIFURCATED3Cleared 510(K)
- K830743POROUS TIP ENDOCARDIAL LEAD3Cleared 510(K)
- K823893MODEL MZ PACEMAKER LEAD-VARIOUS3Cleared 510(K)
- K823889MODEL JY PACEMAKER LEAD - VARIOUS3Cleared 510(K)
- K823897MODEL SF. D&SX.D PACEMAKER LEADS3Cleared 510(K)
- K823896MODEL FF..D & FX..D PACEMAKER LEADS3Cleared 510(K)
- K823895MODEL RF. D&RX..D PACEMAKER LEADS3Cleared 510(K)
- K823894MODEL RZ PACEMAKER LEAD VARIOUS3Cleared 510(K)
- K823892MODEL SZ PACEMAKER LEAD-VARIOUS3Cleared 510(K)
- K823898MODEL MF..D & MX..D PACEMAKER LEADS3Cleared 510(K)
- K830828IMPLANTABLE PACING LEAD CCS MODEL SV-1013Cleared 510(K)
- K830950VASCULAR PRODUCTS IMPLANTABLE PACING3Cleared 510(K)
- K830782LIFELINE ENDOCARDIAL PACING LEAD #479-053Cleared 510(K)
- K823891MODEL KY PACEMAKER LEAD - VARIOUS3Cleared 510(K)
- K823890MODEL ZY PACEMAKER LEAD-VARIOUS3Cleared 510(K)
- K830457PACING LEAD #PMA F 8603Cleared 510(K)
- K830464PACEMAKER ELECTRODE PERM. & TEMP3Cleared 510(K)
- K830463LIFELINE UNIPOLAR J-LEAD #483-053Cleared 510(K)
- P800041ENDOCARDIAL PACEMAKER LEAD W/CARBON TIP3PMA Approval
- K823508LIFELINE -UNIPOLAR LEAD #487-053Cleared 510(K)
- K823452ELECTRODE LEAD OF SILICONE ELASTOMETER3Cleared 510(K)
- K823033ELECTRODE, PACEMAKER, PERMANENT3Cleared 510(K)
- K823447IMPLANTABLE PACING LEAD, TINED #3262 &3Cleared 510(K)
- K823448IMPLANTABLE PACING LEAD TINED #3390 &3Cleared 510(K)
- K823446PRODUCTS IMPLANTABLE PACING LEAD,TINED3Cleared 510(K)
- K822781MEDTRONIC MODELS 4011 & 45113Cleared 510(K)
- K822239COAXIAL BIPOLAR PACING ELECTRODE3Cleared 510(K)
- K821947FASTPASS IMPLANTABLE ENDOCARD. PACING3Cleared 510(K)
- K821889POROUS SURFACED PLATINUM IRIDIUM3Cleared 510(K)
- K820989MEDTRONIC #69933Cleared 510(K)
- K820487IMPLANTIBLE SUTURE SLEEVE3Cleared 510(K)
- K820767BIOPOLAR TINED ENDOCARDIAL LEAD 403B/603Cleared 510(K)
- K812049STOCKERT CARDIAC PACING ELECTRODES3Cleared 510(K)
- K820262PERMANENT & TEMPORARY PACEMAKER ELECTR.3Cleared 510(K)
- K820121LASERPOR AP ATRIAL ENDOCARD. ELECTR. LD.3Cleared 510(K)
- K812905PERMANENT ENDOCARD. UNIPOLAR TINED LEAD3Cleared 510(K)
- K813205INTERSEPT CARDIOTOMY RESERVOIR/FILTER3Cleared 510(K)
- K812830APC IMPLANTABLE PACING LEAD3Cleared 510(K)
- K812807APC IMPLANTABLE PACING LEADS3Cleared 510(K)
- K813134ATRIAL ENDOCARDIAL ELECTRODE LEAD J-TIP3Cleared 510(K)
- K813028POLY-FLEX PACING LEADS3Cleared 510(K)
- K810286PACEPATH IMPLANT. ENDOCARD. PACING LEAD3Cleared 510(K)
- K810139ELECTRODE, PACEMAKER, PERMANENT3Cleared 510(K)
- K812989INTERMEDICS POLYFLEX-MODEL 493-03 LEAD3Cleared 510(K)
- K812991INTERMEDICS POLYFLEX-MODEL 483-04 LEAD3Cleared 510(K)
- K812990INTERMEDICS POLYFLEX-MODEL 483-03 LEAD3Cleared 510(K)
- K812815MODEL 833 ENDOCARDIAL TINED LEAD3Cleared 510(K)
- K812816MODEL 841 ENDOCARDIAL TINED LEAD3Cleared 510(K)
- K812599MEDTRONIC #49513Cleared 510(K)
- K811593ATRIAL ENDOCARDIAL ELECTRODE LEAD OF J3Cleared 510(K)
- K812245INTERMEDICS POLY FLEX ENDOCARDIAL ATRIAL3Cleared 510(K)
- K812221INTERMEDICS POLY FLEX EPICARDIAL SUTURE3Cleared 510(K)
- K812270PERM. ENDOCARDIAL UNIPOLAR TINED ATRIAL3Cleared 510(K)
- K811200PACEPATH IMPLANTABLE ENDOCARD. PACING LD3Cleared 510(K)
- K810494TYPE FH ENDOCARDIAL LEAD3Cleared 510(K)
- K811878MODEL B BIPOLAR ENDOCARDIAL LEAD3Cleared 510(K)
- K811879MODEL A UNIPOLAR ENDOCARDIAL LEAD3Cleared 510(K)
- K811877MODEL C UNIPOLAR ENDOCARDIAL LEAD3Cleared 510(K)
- K811876MODEL D BIPOLAR ENDOCARDIAL LEAD3Cleared 510(K)
- K810928ENDOCARDIAL ELECTRODE3Cleared 510(K)
- K811539CORDIS ENCOR PEWENOUS VENTRICULAR BIPOL3Cleared 510(K)
- K811106INTERMEDICS POLY FLEX ENDOCARDIAL PACING3Cleared 510(K)
- K810399APC IMPLANTABEL PACING LEAD, MODEL 32643Cleared 510(K)
- K810398APC IMPLANTABLE PACING LEAD, MODEL 32663Cleared 510(K)
- K810397APC IMPLANTABLE PACING LEAD-FLANGE #32603Cleared 510(K)
- K810396APC IMPLANTABLE PACING LEAD, TINED #32623Cleared 510(K)
- K810493TYPE N ENDOCARDIAL LEAD3Cleared 510(K)
- K810492TYPE YR ENDOCARDIAL LEAD3Cleared 510(K)
- K810491TYPE YC ENDOCARDIAL LEAD3Cleared 510(K)
- K810582ELECTRODE, PACEMAKER PERMANENT3Cleared 510(K)
- K810432CORDIS PERVENOUS ATRIAL LEAD3Cleared 510(K)
- K810333TEMPORARY MYOCARDIAL PACING LEAD#64003Cleared 510(K)
- K802295POLY FLEX IMPLANTABLE PACING LEAD3Cleared 510(K)
- K810202CORDIS MULTIFILAR PERVENOUS VENTRIC. LD3Cleared 510(K)
- K802816ENDOCARDIAL LEADS 414S & 515S3Cleared 510(K)
- K802553PERM. ENDOCARDIAL UNIPOLAR WEDGE URETHAN3Cleared 510(K)
- K802547PERMANENT & TEMP. PACEMAKER ELECTRODE3Cleared 510(K)
- K802552PERM. ENDOCARDIAL UNIPOLAR TINED/WEDGE3Cleared 510(K)
- K802413IMPLANT. ENDOCARDIAL DISH TIP ELECT. LDS3Cleared 510(K)
- K803042SIEMENS-ELEMA ENDOCARDIAL LEAD 402S3Cleared 510(K)
- K802968UNIPOLAR ENDOCARDIAL LASER DRILLED ELEC3Cleared 510(K)
- K801284LOW PROFILE LEAD CONNECTOR MODIFICATION (4002)3Cleared 510(K)
- K801172INTERMEDICS' LIFELINE TLE ENDOCARDIAL3Cleared 510(K)
- K800870MEDTRONIC MODEL 69583Cleared 510(K)
- K802293POLYFLEX IMPLANTABLE PACING LEAD3Cleared 510(K)
- K801416PACEPATH MODEL 8103Cleared 510(K)
- K801792IMPLANTABLE ENDOCARDIAL POROUS TIP ELEC.3Cleared 510(K)
- K801455LEAD, ENDOCARDIAL, TINED, BIPOLAR, 5MM3Cleared 510(K)
- K801417PACEPATH MODEL 8193Cleared 510(K)
- K800944MEDTRONIC MODEL 695753Cleared 510(K)
- K800795PERMANENT & TEMP. PACEMAKER ELECTRODE3Cleared 510(K)
- K792301LIFELINE TLE J-SHAPED ATRIAL ENDOCARDIAL3Cleared 510(K)
- K792300LIFELINE TLE (TRAEBECULAR LODGING ELEC3Cleared 510(K)
- K800354LEAD, TINED PACING, IMPLANTABLE3Cleared 510(K)
- K800891RESTERILIZATION OF IMPLANTABLE ELECTRODE3Cleared 510(K)
- K800355LEAD, SUTURELESS MYOCARDIAL3Cleared 510(K)
- K800352PACEMAKER, ELECTRODE3Cleared 510(K)
- K800351PACEMAKER, ELECTRODE, PERM. & TEMP.3Cleared 510(K)
- K800350ENDOCARD. PACING LEAD STD. LENGTH PL2023Cleared 510(K)
- K800349ENDOCARD. PACING LEAD LONG LENGTH PL2003Cleared 510(K)
- K800348UNIPOLAR LEAD CONFIGURATION CONDUCTOR3Cleared 510(K)
- K800347PERM. INPLANT ENDOCARD. PAC. LEAD3Cleared 510(K)
- K792604LIFELINE TLE ENDOCARDIAL PACING LEAD,3Cleared 510(K)
- K792321IMPLANTABLE END. MUSH. TIP LEADS030-2243Cleared 510(K)
- K792379CARDIAC PACING ELECTRODE3Cleared 510(K)
- K792387IMPLANTABLE ENDOCARDIAL TINED ELECTRODE3Cleared 510(K)
- K792168LIFELINE - ENDOCARDIAL PACING LEAD3Cleared 510(K)
- K791768CORDIS PERMANENT PERVENOUS CARDIAC LEADS3Cleared 510(K)
- K791769MEDTRONIC MODEL 69573Cleared 510(K)
- K791732IMPLANTABLE ENDOCARDIAL SCREW-IN ELEC3Cleared 510(K)
- K790143VENTRICULAR LEAD, MODEL 69593Cleared 510(K)
- K791378MODEL 482-01 BIPOLAR COAXIAL PACING LEAD3Cleared 510(K)
- K791377MODEL 484-01 BIPOLAR COAXIAL PACING LEAD3Cleared 510(K)
- K791667MEDTRONIC MODELS 69914/699OU3Cleared 510(K)
- K791552MODELS UL-804 AND BL-801 UNIPOLAR LEADS3Cleared 510(K)
- K790983BIFLEX TM TEMPORARY PACING PROBE3Cleared 510(K)
- K790429MEDTRONIC MODEL 69573Cleared 510(K)
- K790988MODEL 6971 W/ DBS WIRE3Cleared 510(K)
- K782018LEADS, IMPLANTABLE CARDIAC PACEMAKERS3Cleared 510(K)
- K790548ENDOCARDIAL PACING LEAD, MODEL 476-013Cleared 510(K)
- K790766MEDTRONIC MODELS 6907/69013Cleared 510(K)
- K790344BIPOLAR PERNENOUS VENTRICULAR LEAD3Cleared 510(K)
- K790462MEDTRONIC MODEL 69723Cleared 510(K)
- K790386LEAD MODELS MUM 1260, MUM 12903Cleared 510(K)
- K790074MEDTRONIC MODEL 69713Cleared 510(K)
- K790261MEDTRONIC TEMPTRON3Cleared 510(K)
- K790116CARDIOTOMY RESERVOIR CR-20003Cleared 510(K)
- K781570SUTURELESS MUOCARDINE PACING LEADS 4713Cleared 510(K)
- K781525ENDOCARIDAL PACING LEAD UNIPOLAR 4773Cleared 510(K)
- K781497LIFELINE PACING LEAD MODEL 465-013Cleared 510(K)
- K781499LIFELINE PACING LEAD MODEL 467-013Cleared 510(K)
- K781498LIFELINE BIPOLAR PACING LEAD MOD. 466-013Cleared 510(K)
- K782087LEAD, SUTURELESS MYOCARDIAL3Cleared 510(K)
- K781624PACING LEAD MODEL BUS 860, BUS 8903Cleared 510(K)
- K782004LEAD, TIMED PACING, IMPLANTABLE3Cleared 510(K)
- K781620PACING LEAD MODELS, MDM 1060, MDM 10903Cleared 510(K)
- K781619PACING LEAD MODELS SA, 350, SAM 5003Cleared 510(K)
- K781625PACING LEAD MODEL MVM 860, MVM 8903Cleared 510(K)
- K781623PACING MODELS MUM 860, MUM 8903Cleared 510(K)
- K781621PACING LEAD MODELS, MAM 1260 MAM 12903Cleared 510(K)
- K781849ELECTRODES, IMPLANTABLE WITH ADAPTER3Cleared 510(K)
- K781456ENDOCARDIAL BIPOLAR LEAD3Cleared 510(K)
- K781326UNIPOPLAR ENDOCARDIAL LEADS3Cleared 510(K)
- K781776PACING LEADS MODEL UL-811 AND UL-8133Cleared 510(K)
- K780246PACEMAKER, ELECTRODE, PERMANENT & TEMP.3Cleared 510(K)
- K780623ENDOCARDIAL ATRIAL PACING LEAD, M. 69943Cleared 510(K)
- K780622BIPOLAR ENDOCARDIAL PACING LEAD, M. 69023Cleared 510(K)
- K780621LEAD, PACING, ATRIAL, ENDOCARDIAL, TINED3Cleared 510(K)
- K780569L-12, L-21, AND L-22 ELECTRODES3Cleared 510(K)
- K780446SUTURELESS MYOCARDIAL PACING LEAD3Cleared 510(K)
- K772309ENDOCARDIAL PACING ELECTRODE3Cleared 510(K)
- K772197PACEMAKER, PERM. & TEMP., ELECTRODE3Cleared 510(K)
- K772331RESTERIL. OF IMPLANT. ELECT. & ADAPTER3Cleared 510(K)
- K772203VENTRICULAR LEADS3Cleared 510(K)
- K772104PACING LEAD MODEL 6991A3Cleared 510(K)
- K772103BIPOLAR LEADS, DISP.3Cleared 510(K)
- K771565ENDOCARD. PACIN/ LEAD-LONG LENGTH PL2003Cleared 510(K)
- K771567ENDOCARD. PACING LEAD-LONG LENGTH PL2033Cleared 510(K)
- K771566ENDOCAR. PACING LEAD-STD. LENGTH PL2023Cleared 510(K)
- K771564ENDOCARD. PACIN/ LEAD-STD. LENGTH PL1003Cleared 510(K)
- K771528CATHETER, CARDIAC PACING, ENDOCARDIAL3Cleared 510(K)
- K770468UNIPOLAR LEAD CONFIGURATION CONDUCTOR3Cleared 510(K)
- K770214TEMP. PERVENOUS LEAD W/REMOTE ANODE3Cleared 510(K)
- K770416LEAD, HEART, BUTTERFLY CLAMP3Cleared 510(K)
- K770285BALL TIP, MODEL #030-1883Cleared 510(K)
- K770284BALL TIP, MODEL #030-1853Cleared 510(K)
- K770283WEDGE TIP, SMALL, MODEL #030-1943Cleared 510(K)
- K770282WEDGE TIP, SMALL, MODEL #030-1913Cleared 510(K)
- K770195PERM. IMPLANT. ENDOCARDIAL PAC. LEAD3Cleared 510(K)
- K760714ENDO-LOK L-40 ENDOCARDIAL PACING ELECT.3Cleared 510(K)
- K760513ELECTRODE, TEMPORARY MYOCARDIAL3Cleared 510(K)
- K760443CARDIAC ELECTRODE3Cleared 510(K)
- 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
- 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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ELC 35-UP MODEL NUMBER 116015 AND ELC 54-UP MODEL NUMBER 115606
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K965106
- 510(k) Type
- Traditional
- Applicant
- BIOTRONIK, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent - Subject to Tracking & Post-Market Surveillance
- Decision Date
- 1/27/1998
- Days to Decision
- 403 days