Pacemaker Lead Adaptor
FDA product code DTD · Class II (moderate risk) · 21 CFR 870.3620 · Cardiovascular
103510(k) clearances
0PMA approvals
0recalls
Implantimplanted device
Manufacturers
- Pacesetter Systems 20
- Medtronic Vascular 19
- Intermedics, Inc. 14
- Telectronics, Inc. 8
- Biotronik, Inc. 6
- Cardiac Pacemakers, Inc. 5
- Telectronics Pacing Systems, Inc. 5
- Oscor, Inc. 4
- Cordis Corp. 3
- R.E. Brown Co., Inc. 3
- Daig Corp. 3
- Biotronik Sales, Inc. 2
- Arco Medical Products Co. 2
- Cardiac Control Systems, Inc. 1
- Possis Medical, Inc. 1
- Siemens Elema AB 1
- Metronic, Inc. 1
- Siemens-Pacesetter, Inc. 1
- Oscor Medical Corp. 1
- Pacesetter, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K143463 | IS4/DF4 Port PlugDTD · Traditional | Oscor, Inc. | 03/19/2015SE |
| K132008 | 6981M Lead Extender Kit, 6984M Lead Extender Kit, 6986M Lead Extender Kit, 5866-24M Lead…DTD · Special | Medtronic, Inc. | 07/30/2013SE |
| K041574 | Cpi Lead Adapters, Models 6017, 6018 and 6020DTD · Special | Guidant Corporation | 07/12/2004SE |
| K031164 | Pacing Lead Adaptors, Bipolar, Models Ilink-Bis, Ilink-BlvDTD · Special | Oscor, Inc. | 06/19/2003ST |
| K024156 | Pacing Lead Extensions, Bipolar, Pacing Lead Adaptors, Unipolar/Bipolar,Pacing Lead…DTD · Special | Oscor, Inc. | 01/14/2003SE |
| K010787 | Pacing Lead Bipolar Adapters and ExtensionsDTD · Traditional | Oscor, Inc. | 05/22/2001SE |
| K003454 | A1-CS-SB Y-Adapter, Model 124 871DTD · Special | Biotronik, Inc. | 01/18/2001ST |
| K000210 | Modification to Model 5866-37M Lead Adaptor KitDTD · Special | Medtronic Vascular | 02/23/2000ST |
| K982220 | Model 2872 Bipolar Lead Adaptor KitDTD · Traditional | Medtronic Vascular | 10/15/1998ST |
| K971930 | Bk-N Sealing CapDTD · Traditional | Biotronik, Inc. | 08/14/1997PT |
| K970388 | A1-A,ABP,B,MBP, Lead Connectors; Peh Adapter SleeveDTD · Traditional | Biotronik, Inc. | 08/14/1997PT |
| K970204 | Bk-A; Bk-B; Bk-Is Sealing CapDTD · Traditional | Biotronik, Inc. | 04/29/1997SE |
| K950140 | IS-1/QUADRIPOLAR Terminal Cap, Part Number 6011069DTD · Traditional | Pacesetter, Inc. | 04/06/1995SE |
| K934899 | Bifurcated Lead Adaptors, 3.2MM & 5.0 MMDTD · Traditional | Telectronics Pacing Systems, Inc. | 05/12/1994SE |
| K925168 | Miscellaneous Pacing LeadDTD · Traditional | Oscor Medical Corp. | 05/03/1994SE |
| K921318 | Adapting Sleeve Kit Model 4023DTD · Traditional | Siemens-Pacesetter, Inc. | 08/03/1992SE |
| K915724 | Model 6984M Lead Extender KitDTD · Traditional | Medtronic Vascular | 02/18/1992SE |
| K912773 | Unipolar Upsizing AdaptorDTD · Traditional | Telectronics Pacing Systems, Inc. | 10/23/1991SE |
| K911142 | Lead Terminal Pin Caps, Various ModelsDTD · Traditional | Biotronik, GmbH & Co. | 08/09/1991SE |
| K911302 | Models 5866-24M/5866-38M/5866-40M/6986M Adapt KitDTD · Traditional | Medtronic Vascular | 07/30/1991SE |
| K911827 | Model 5866-9M & Model 6981MDTD · Traditional | Metronic, Inc. | 07/23/1991SE |
| K911048 | Model 5857-3M Lead End Cap KitDTD · Traditional | Medtronic Vascular | 04/18/1991SE |
| K910630 | Model 6985M Temporary Unipolar Lead Extender KitDTD · Traditional | Medtronic Vascular | 04/18/1991SE |
| K910112 | Bifurcated VS-1 to VS-1 Lead AdaptorDTD · Traditional | Telectronics Pacing Systems, Inc. | 02/25/1991SE |
| K904575 | Model 5866-37M Lead Adaptor KitDTD · Traditional | Medtronic Vascular | 02/01/1991SE |
| K902889 | A1-A,A1-B,A1-ABP,A1-MBP,A1-Z,A6-A,A6-B,PEH Pace.DTD · Traditional | Biotronik, GmbH & Co. | 08/23/1990SE |
| K900512 | Siemens Elema Models 4020T and 4021T AdaptersDTD · Traditional | Pacesetter Systems | 06/25/1990SE |
| K900627 | Model 5866-34 Lead Adaptor KitDTD · Traditional | Medtronic Vascular | 04/20/1990SE |
| K896438 | Upsizing Lead Adapters 5.0MM Peel-Away AdapterDTD · Traditional | Telectronics Pacing Systems, Inc. | 04/10/1990SE |
| K900605 | 3.2-5MM Unipolar Lead Upsizing Kit, Model Ak 100DTD · Traditional | Possis Medical, Inc. | 03/06/1990SE |
| K890895 | Implantable Adaptor 033-380DTD · Traditional | Telectronics, Inc. | 03/06/1990SE |
| K895971 | Telectronics Pacing Systems VS-1 to 6MM UpsizingDTD · Traditional | Telectronics Pacing Systems, Inc. | 02/22/1990SE |
| K894976 | Alternate Packaging Conf. of Pacemaker Lead Adap.DTD · Traditional | Medtronic Vascular | 10/12/1989SE |
| K894718 | Adaptaid(Tm) Adapter Sleeve Model 366-33DTD · Traditional | Intermedics, Inc. | 09/05/1989SE |
| K870562 | Daig Pacemaker Lead AdaptorDTD · Traditional | Daig Corp. | 03/03/1987SE |
| K862656 | Pacemaker Lead AdapterDTD · Traditional | Cordis Corp. | 07/30/1986SE |
| K860832 | Model 366-08 Adaptaid Connector AdapterDTD · Traditional | Intermedics, Inc. | 03/31/1986SE |
| K854997 | Implantable Electrode Adaptor AssemblyDTD · Traditional | Telectronics, Inc. | 02/12/1986SE |
| K850968 | Medtronic Model 4016 Bipolar Endocardial Screw-InDTD · Traditional | Medtronic Vascular | 08/29/1985SE |
| K844814 | Biopore 493-05 Endocardial Implantable Pacing LeadDTD · Traditional | Intermedics, Inc. | 08/29/1985SE |
| K851897 | CCS Model AV-106 Implantable A-V Data LeadDTD · Traditional | Cardiac Control Systems, Inc. | 08/09/1985SE |
| K852356 | Medtronic Model 5561DTD · Traditional | Medtronic Vascular | 08/06/1985SE |
| K852253 | 329 Cordis Encor Prevenous Artrial & VentricularDTD · Traditional | Cordis Corp. | 07/29/1985SE |
| K851458 | Model 493-04 Polyflex R Implantable Pacing LeadDTD · Traditional | Intermedics, Inc. | 07/11/1985SE |
| K851457 | Model 483-06 Polyflex Implantable Pacing LeadDTD · Traditional | Intermedics, Inc. | 07/11/1985SE |
| K851890 | Medtronic 5064DTD · Traditional | Medtronic Vascular | 06/19/1985SE |
| K851665 | Pacesetter Systems, Model 458 Adapter SleeveDTD · Traditional | Pacesetter Systems | 05/21/1985SE |
| K851145 | Pacesetter Systems Inc. Endocardial Finned LeadDTD · Traditional | Pacesetter Systems | 04/19/1985SE |
| K850652 | Pacesetter Systems, Endocardial Firm LeadDTD · Traditional | Pacesetter Systems | 04/10/1985SE |
| K850576 | Pacesetter Sys, Endocardial, Ventricular, BipolarDTD · Traditional | Pacesetter Systems | 03/06/1985SE |
| K844974 | Medtronic 5061 Endocardial Pacing LeadDTD · Traditional | Medtronic Vascular | 03/06/1985SE |
| K844857 | Pacesetter Systems, Inc. Endocardial Screw-In LeadDTD · Traditional | Pacesetter Systems | 02/14/1985SE |
| K841451 | Biotronik Dy-UnipolarDTD · Traditional | Biotronik Sales, Inc. | 02/07/1985SE |
| K841450 | Biotronik DNP UnipolarDTD · Traditional | Biotronik Sales, Inc. | 02/07/1985SE |
| K844687 | Medtronic Model 6912DTD · Traditional | Medtronic Vascular | 02/01/1985SE |
| K842145 | Transvenous Tined Ventricular LeadDTD · Traditional | Medtronic Vascular | 01/18/1985SE |
| K842065 | Epicardial, Unipolar Lead 4951DTD · Traditional | Medtronic Vascular | 01/18/1985SE |
| K843703 | Permathane 865 & 867 Unipolar PolyurethDTD · Traditional | Pacesetter Systems | 01/08/1985SE |
| K841227 | Bipolar Endocardial Lead 406LDTD · Traditional | Siemens Elema AB | 11/27/1984SE |
| K843060 | SentraDTD · Traditional | Cardiac Pacemakers, Inc. | 09/20/1984SE |
| K841885 | Fastpass Implantable Endocardial PacDTD · Traditional | Pacesetter Systems | 08/03/1984SE |
| K841739 | Model 866 Permathane Bipolar, CoaxialDTD · Traditional | Pacesetter Systems | 08/03/1984SE |
| K840026 | Implantable Electrode Unipolar AdaptDTD · Traditional | Telectronics, Inc. | 05/23/1984SE |
| K840025 | Implantable Electrode Bipolar AdaptDTD · Traditional | Telectronics, Inc. | 05/23/1984SE |
| K831160 | Lead Adapters #'S 6016,6022,6017 EtcDTD · Traditional | Cardiac Pacemakers, Inc. | 05/09/1983SE |
| K822704 | Model 366-07 Adapt Aid Lead AdapterDTD · Traditional | Intermedics, Inc. | 11/24/1982SE |
| K821549 | Pacemaker 445 AdapterDTD · Traditional | Pacesetter Systems | 06/02/1982SE |
| K821548 | Pacemaker Connector PlugDTD · Traditional | Pacesetter Systems | 06/02/1982SE |
| K821547 | Pacemaker Unipolar AdapterDTD · Traditional | Pacesetter Systems | 06/02/1982SE |
| K820935 | Model 5866-26 Lead Adapter KitDTD · Traditional | Medtronic Vascular | 04/16/1982SE |
| K813154 | Adapting SleeveDTD · Traditional | Pacesetter Systems | 12/02/1981SE |
| K813152 | Electrode Terminal CapDTD · Traditional | Pacesetter Systems | 12/02/1981SE |
| K813151 | Vitatron InsertDTD · Traditional | Pacesetter Systems | 12/02/1981SE |
| K812756 | Adaptaid #365-38DTD · Traditional | Intermedics, Inc. | 10/29/1981SE |
| K812812 | Intermedics Adaptaid Step-Down AdapterDTD · Traditional | Intermedics, Inc. | 10/27/1981SE |
| K811920 | Adaptaid Lead Adapter, #365-17DTD · Traditional | Intermedics, Inc. | 08/13/1981SE |
| K811938 | Adaptaid Lead Adapter #365-25DTD · Traditional | Intermedics, Inc. | 08/07/1981SE |
| K811349 | Model 5866-24 Lead Adaptor KitDTD · Traditional | Medtronic Vascular | 06/30/1981SE |
| K810551 | Pacemaker Lead AdapterDTD · Traditional | Pacesetter Systems | 04/23/1981SE |
| K810245 | Implantable Pacemaker Lead AdapterDTD · Traditional | Intermedics, Inc. | 03/04/1981SE |
| K802407 | Pacemaker Lead Adaptor Model 431DTD · Traditional | Pacesetter Systems | 10/31/1980SE |
| K802077 | Unipolar to Bipolar Pulse Gen. AdapterDTD · Traditional | Cardiac Pacemakers, Inc. | 10/23/1980SE |
| K801039 | Adaptaid Helical Coil Adapter 365-14DTD · Traditional | Intermedics, Inc. | 07/21/1980SE |
| K801038 | Adaptaid Elema Lead Adapter Kit 365-17DTD · Traditional | Intermedics, Inc. | 07/08/1980SE |
| K801040 | GE Lead Adapter, Model 345-01DTD · Traditional | Intermedics, Inc. | 06/30/1980SE |
| K800353 | Adapter KitDTD · Traditional | Daig Corp. | 05/28/1980SE |
| K790218 | Bipolar Lead Adaptor, Model BA-415DTD · Traditional | Pacesetter Systems | 08/10/1979SE |
| K790436 | Implantable Heart Lead Terminal AdapterDTD · Traditional | Arco Medical Products Co. | 05/14/1979SE |
| K790468 | Implantable Heart Lead ExtenderDTD · Traditional | Arco Medical Products Co. | 03/19/1979SE |
| K781824 | Electrode, Model 030-324/4 GuageDTD · Traditional | Telectronics, Inc. | 02/08/1979SE |
| K781823 | Electrode, Model 030-326DTD · Traditional | Telectronics, Inc. | 02/08/1979SE |
| K781822 | Electrode, Model 030-324DTD · Traditional | Telectronics, Inc. | 02/08/1979SE |
| K782097 | Electrode Lead Model 030-198DTD · Traditional | Telectronics, Inc. | 12/22/1978SE |
| K781864 | Adapter KitDTD · Traditional | Daig Corp. | 12/19/1978SE |
| K781627 | Pacing Lead Adapter Model Adb 21DTD · Traditional | R.E. Brown Co., Inc. | 12/08/1978SE |
| K781626 | Pacing Lead Adapter, Acv 14, Acv 23DTD · Traditional | R.E. Brown Co., Inc. | 12/08/1978SE |
| K781622 | Pacing Lead Adapter Model Acs 16DTD · Traditional | R.E. Brown Co., Inc. | 12/08/1978SE |
| K772058 | Lead Adaptor Kit Model 5866-21DTD · Traditional | Medtronic Vascular | 11/03/1977SE |
| K771642 | Adapter A-413DTD · Traditional | Pacesetter Systems | 09/14/1977SE |
| K771641 | Universal Lead Adapter, UA-414DTD · Traditional | Pacesetter Systems | 09/14/1977SE |
| K770478 | Adapter, CordisDTD · Traditional | Cordis Corp. | 03/30/1977SE |
| K770199 | Lead Extender Model 6516DTD · Traditional | Cardiac Pacemakers, Inc. | 02/07/1977SE |
| K770042 | Adapter, Lead, General ElectricDTD · Traditional | Cardiac Pacemakers, Inc. | 01/12/1977SE |