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
- K143463IS4/DF4 Port Plug2Cleared 510(K)
- K1320086981M LEAD EXTENDER KIT, 6984M LEAD EXTENDER KIT, 6986M LEAD EXTENDER KIT, 5866-24M LEAD ADAPTOR KIT, 5866-38M LEAD ADAP2Cleared 510(K)
- K041574CPI LEAD ADAPTERS, MODELS 6017, 6018 AND 60202Cleared 510(K)
- K031164PACING LEAD ADAPTORS, BIPOLAR, MODELS ILINK-BIS, ILINK-BLV2Cleared 510(K)
- K024156PACING LEAD EXTENSIONS, BIPOLAR, PACING LEAD ADAPTORS, UNIPOLAR/BIPOLAR,PACING LEAD ADAPTORS, UNIPOLAR/BIPOLAR2Cleared 510(K)
- K010787PACING LEAD BIPOLAR ADAPTERS AND EXTENSIONS2Cleared 510(K)
- K003454A1-CS-SB Y-ADAPTER, MODEL 124 8712Cleared 510(K)
- K000210MODIFICATION TO MODEL 5866-37M LEAD ADAPTOR KIT2Cleared 510(K)
- K982220MODEL 2872 BIPOLAR LEAD ADAPTOR KIT2Cleared 510(K)
- K971930BK-N SEALING CAP2Cleared 510(K)
- K970388A1-A,ABP,B,MBP, LEAD CONNECTORS; PEH ADAPTER SLEEVE2Cleared 510(K)
- K970204BK-A; BK-B; BK-IS SEALING CAP2Cleared 510(K)
- K950140IS-1/QUADRIPOLAR TERMINAL CAP, PART NUMBER 60110692Cleared 510(K)
- K934899BIFURCATED LEAD ADAPTORS, 3.2MM & 5.0 MM2Cleared 510(K)
- K925168MISCELLANEOUS PACING LEAD2Cleared 510(K)
- K921318ADAPTING SLEEVE KIT MODEL 40232Cleared 510(K)
- K915724MODEL 6984M LEAD EXTENDER KIT2Cleared 510(K)
- K912773UNIPOLAR UPSIZING ADAPTOR2Cleared 510(K)
- K911142LEAD TERMINAL PIN CAPS, VARIOUS MODELS2Cleared 510(K)
- K911302MODELS 5866-24M/5866-38M/5866-40M/6986M ADAPT KIT2Cleared 510(K)
- K911827MODEL 5866-9M & MODEL 6981M2Cleared 510(K)
- K911048MODEL 5857-3M LEAD END CAP KIT2Cleared 510(K)
- K910630MODEL 6985M TEMPORARY UNIPOLAR LEAD EXTENDER KIT2Cleared 510(K)
- K910112BIFURCATED VS-1 TO VS-1 LEAD ADAPTOR2Cleared 510(K)
- K904575MODEL 5866-37M LEAD ADAPTOR KIT2Cleared 510(K)
- K902889A1-A,A1-B,A1-ABP,A1-MBP,A1-Z,A6-A,A6-B,PEH PACE.2Cleared 510(K)
- K900512SIEMENS ELEMA MODELS 4020T AND 4021T ADAPTERS2Cleared 510(K)
- K900627MODEL 5866-34 LEAD ADAPTOR KIT2Cleared 510(K)
- K896438UPSIZING LEAD ADAPTERS 5.0MM PEEL-AWAY ADAPTER2Cleared 510(K)
- K9006053.2-5MM UNIPOLAR LEAD UPSIZING KIT, MODEL AK 1002Cleared 510(K)
- K890895IMPLANTABLE ADAPTOR 033-3802Cleared 510(K)
- K895971TELECTRONICS PACING SYSTEMS VS-1 TO 6MM UPSIZING2Cleared 510(K)
- K894976ALTERNATE PACKAGING CONF. OF PACEMAKER LEAD ADAP.2Cleared 510(K)
- K894718ADAPTAID(TM) ADAPTER SLEEVE MODEL 366-332Cleared 510(K)
- K870562DAIG PACEMAKER LEAD ADAPTOR2Cleared 510(K)
- K862656PACEMAKER LEAD ADAPTER2Cleared 510(K)
- K860832MODEL 366-08 ADAPTAID CONNECTOR ADAPTER2Cleared 510(K)
- K854997IMPLANTABLE ELECTRODE ADAPTOR ASSEMBLY2Cleared 510(K)
- K850968MEDTRONIC MODEL 4016 BIPOLAR ENDOCARDIAL SCREW-IN2Cleared 510(K)
- K844814BIOPORE 493-05 ENDOCARDIAL IMPLANTABLE PACING LEAD2Cleared 510(K)
- K851897CCS MODEL AV-106 IMPLANTABLE A-V DATA LEAD2Cleared 510(K)
- K852356MEDTRONIC MODEL 55612Cleared 510(K)
- K852253329 CORDIS ENCOR PREVENOUS ARTRIAL & VENTRICULAR2Cleared 510(K)
- K851458MODEL 493-04 POLYFLEX R IMPLANTABLE PACING LEAD2Cleared 510(K)
- K851457MODEL 483-06 POLYFLEX IMPLANTABLE PACING LEAD2Cleared 510(K)
- K851890MEDTRONIC 50642Cleared 510(K)
- K851665PACESETTER SYSTEMS, MODEL 458 ADAPTER SLEEVE2Cleared 510(K)
- K851145PACESETTER SYSTEMS INC. ENDOCARDIAL FINNED LEAD2Cleared 510(K)
- K850652PACESETTER SYSTEMS, ENDOCARDIAL FIRM LEAD2Cleared 510(K)
- K850576PACESETTER SYS, ENDOCARDIAL, VENTRICULAR, BIPOLAR2Cleared 510(K)
- K844974MEDTRONIC 5061 ENDOCARDIAL PACING LEAD2Cleared 510(K)
- K844857PACESETTER SYSTEMS, INC. ENDOCARDIAL SCREW-IN LEAD2Cleared 510(K)
- K841451BIOTRONIK DY-UNIPOLAR2Cleared 510(K)
- K841450BIOTRONIK DNP UNIPOLAR2Cleared 510(K)
- K844687MEDTRONIC MODEL 69122Cleared 510(K)
- K842145TRANSVENOUS TINED VENTRICULAR LEAD2Cleared 510(K)
- K842065EPICARDIAL, UNIPOLAR LEAD 49512Cleared 510(K)
- K843703PERMATHANE 865 & 867 UNIPOLAR POLYURETH2Cleared 510(K)
- K841227BIPOLAR ENDOCARDIAL LEAD 406L2Cleared 510(K)
- K843060SENTRA2Cleared 510(K)
- K841885FASTPASS IMPLANTABLE ENDOCARDIAL PAC2Cleared 510(K)
- K841739MODEL 866 PERMATHANE BIPOLAR, COAXIAL2Cleared 510(K)
- K840026IMPLANTABLE ELECTRODE UNIPOLAR ADAPT2Cleared 510(K)
- K840025IMPLANTABLE ELECTRODE BIPOLAR ADAPT2Cleared 510(K)
- K831160LEAD ADAPTERS #'S 6016,6022,6017 ETC2Cleared 510(K)
- K822704MODEL 366-07 ADAPT AID LEAD ADAPTER2Cleared 510(K)
- K821547PACEMAKER UNIPOLAR ADAPTER2Cleared 510(K)
- K821549PACEMAKER 445 ADAPTER2Cleared 510(K)
- K821548PACEMAKER CONNECTOR PLUG2Cleared 510(K)
- K820935MODEL 5866-26 LEAD ADAPTER KIT2Cleared 510(K)
- K813151VITATRON INSERT2Cleared 510(K)
- K813154ADAPTING SLEEVE2Cleared 510(K)
- K813152ELECTRODE TERMINAL CAP2Cleared 510(K)
- K812756ADAPTAID #365-382Cleared 510(K)
- K812812INTERMEDICS ADAPTAID STEP-DOWN ADAPTER2Cleared 510(K)
- K811920ADAPTAID LEAD ADAPTER, #365-172Cleared 510(K)
- K811938ADAPTAID LEAD ADAPTER #365-252Cleared 510(K)
- K811349MODEL 5866-24 LEAD ADAPTOR KIT2Cleared 510(K)
- K810551PACEMAKER LEAD ADAPTER2Cleared 510(K)
- K810245IMPLANTABLE PACEMAKER LEAD ADAPTER2Cleared 510(K)
- K802407PACEMAKER LEAD ADAPTOR MODEL 4312Cleared 510(K)
- K802077UNIPOLAR TO BIPOLAR PULSE GEN. ADAPTER2Cleared 510(K)
- K801039ADAPTAID HELICAL COIL ADAPTER 365-142Cleared 510(K)
- K801038ADAPTAID ELEMA LEAD ADAPTER KIT 365-172Cleared 510(K)
- K801040GE LEAD ADAPTER, MODEL 345-012Cleared 510(K)
- K800353ADAPTER KIT2Cleared 510(K)
- K790218BIPOLAR LEAD ADAPTOR, MODEL BA-4152Cleared 510(K)
- K790436IMPLANTABLE HEART LEAD TERMINAL ADAPTER2Cleared 510(K)
- K790468IMPLANTABLE HEART LEAD EXTENDER2Cleared 510(K)
- K781824ELECTRODE, MODEL 030-324/4 GUAGE2Cleared 510(K)
- K781823ELECTRODE, MODEL 030-3262Cleared 510(K)
- K781822ELECTRODE, MODEL 030-3242Cleared 510(K)
- K782097ELECTRODE LEAD MODEL 030-1982Cleared 510(K)
- K781864ADAPTER KIT2Cleared 510(K)
- K781622PACING LEAD ADAPTER MODEL ACS 162Cleared 510(K)
- K781627PACING LEAD ADAPTER MODEL ADB 212Cleared 510(K)
- K781626PACING LEAD ADAPTER, ACV 14, ACV 232Cleared 510(K)
- K772058LEAD ADAPTOR KIT MODEL 5866-212Cleared 510(K)
- K771642ADAPTER A-4132Cleared 510(K)
- K771641UNIVERSAL LEAD ADAPTER, UA-4142Cleared 510(K)
- K770478ADAPTER, CORDIS2Cleared 510(K)
- K770199LEAD EXTENDER MODEL 65162Cleared 510(K)
- K770042ADAPTER, LEAD, GENERAL ELECTRIC2Cleared 510(K)
- 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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- OphthalmicReview Panel
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- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
A1-A,ABP,B,MBP, LEAD CONNECTORS; PEH ADAPTER SLEEVE
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K970388
- 510(k) Type
- Traditional
- Applicant
- BIOTRONIK, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent - Subject to Tracking & Post-Market Surveillance
- Decision Date
- 8/14/1997
- Days to Decision
- 192 days