FDA 510(k) Applications for Medical Device Product Code "DTD"
(Pacemaker Lead Adaptor)

FDA 510(k) Number Applicant Device Name Decision Date
K790468 ARCO MEDICAL PRODUCTS CO. IMPLANTABLE HEART LEAD EXTENDER 03/19/1979
K790436 ARCO MEDICAL PRODUCTS CO. IMPLANTABLE HEART LEAD TERMINAL ADAPTER 05/14/1979
K841450 BIOTRONIK SALES, INC. BIOTRONIK DNP UNIPOLAR 02/07/1985
K841451 BIOTRONIK SALES, INC. BIOTRONIK DY-UNIPOLAR 02/07/1985
K902889 BIOTRONIK, GMBH & CO. A1-A,A1-B,A1-ABP,A1-MBP,A1-Z,A6-A,A6-B,PEH PACE. 08/23/1990
K911142 BIOTRONIK, GMBH & CO. LEAD TERMINAL PIN CAPS, VARIOUS MODELS 08/09/1991
K970388 BIOTRONIK, INC. A1-A,ABP,B,MBP, LEAD CONNECTORS; PEH ADAPTER SLEEVE 08/14/1997
K003454 BIOTRONIK, INC. A1-CS-SB Y-ADAPTER, MODEL 124 871 01/18/2001
K970204 BIOTRONIK, INC. BK-A; BK-B; BK-IS SEALING CAP 04/29/1997
K971930 BIOTRONIK, INC. BK-N SEALING CAP 08/14/1997
K851897 CARDIAC CONTROL SYSTEMS, INC. CCS MODEL AV-106 IMPLANTABLE A-V DATA LEAD 08/09/1985
K770042 CARDIAC PACEMAKERS, INC. ADAPTER, LEAD, GENERAL ELECTRIC 01/12/1977
K831160 CARDIAC PACEMAKERS, INC. LEAD ADAPTERS #'S 6016,6022,6017 ETC 05/09/1983
K770199 CARDIAC PACEMAKERS, INC. LEAD EXTENDER MODEL 6516 02/07/1977
K843060 CARDIAC PACEMAKERS, INC. SENTRA 09/20/1984
K802077 CARDIAC PACEMAKERS, INC. UNIPOLAR TO BIPOLAR PULSE GEN. ADAPTER 10/23/1980
K852253 CORDIS CORP. 329 CORDIS ENCOR PREVENOUS ARTRIAL & VENTRICULAR 07/29/1985
K770478 CORDIS CORP. ADAPTER, CORDIS 03/30/1977
K862656 CORDIS CORP. PACEMAKER LEAD ADAPTER 07/30/1986
K800353 DAIG CORP. ADAPTER KIT 05/28/1980
K781864 DAIG CORP. ADAPTER KIT 12/19/1978
K870562 DAIG CORP. DAIG PACEMAKER LEAD ADAPTOR 03/03/1987
K041574 GUIDANT CORPORATION CPI LEAD ADAPTERS, MODELS 6017, 6018 AND 6020 07/12/2004
K812756 INTERMEDICS, INC. ADAPTAID #365-38 10/29/1981
K801038 INTERMEDICS, INC. ADAPTAID ELEMA LEAD ADAPTER KIT 365-17 07/08/1980
K801039 INTERMEDICS, INC. ADAPTAID HELICAL COIL ADAPTER 365-14 07/21/1980
K811938 INTERMEDICS, INC. ADAPTAID LEAD ADAPTER #365-25 08/07/1981
K811920 INTERMEDICS, INC. ADAPTAID LEAD ADAPTER, #365-17 08/13/1981
K894718 INTERMEDICS, INC. ADAPTAID(TM) ADAPTER SLEEVE MODEL 366-33 09/05/1989
K844814 INTERMEDICS, INC. BIOPORE 493-05 ENDOCARDIAL IMPLANTABLE PACING LEAD 08/29/1985
K801040 INTERMEDICS, INC. GE LEAD ADAPTER, MODEL 345-01 06/30/1980
K810245 INTERMEDICS, INC. IMPLANTABLE PACEMAKER LEAD ADAPTER 03/04/1981
K812812 INTERMEDICS, INC. INTERMEDICS ADAPTAID STEP-DOWN ADAPTER 10/27/1981
K822704 INTERMEDICS, INC. MODEL 366-07 ADAPT AID LEAD ADAPTER 11/24/1982
K860832 INTERMEDICS, INC. MODEL 366-08 ADAPTAID CONNECTOR ADAPTER 03/31/1986
K851457 INTERMEDICS, INC. MODEL 483-06 POLYFLEX IMPLANTABLE PACING LEAD 07/11/1985
K851458 INTERMEDICS, INC. MODEL 493-04 POLYFLEX R IMPLANTABLE PACING LEAD 07/11/1985
K132008 MEDTRONIC INC. 6981M LEAD EXTENDER KIT, 6984M LEAD EXTENDER KIT, 6986M LEAD EXTENDER KIT, 5866-24M LEAD ADAPTOR KIT, 5866-38M LEAD ADAP 07/30/2013
K894976 MEDTRONIC VASCULAR ALTERNATE PACKAGING CONF. OF PACEMAKER LEAD ADAP. 10/12/1989
K842065 MEDTRONIC VASCULAR EPICARDIAL, UNIPOLAR LEAD 4951 01/18/1985
K772058 MEDTRONIC VASCULAR LEAD ADAPTOR KIT MODEL 5866-21 11/03/1977
K844974 MEDTRONIC VASCULAR MEDTRONIC 5061 ENDOCARDIAL PACING LEAD 03/06/1985
K851890 MEDTRONIC VASCULAR MEDTRONIC 5064 06/19/1985
K850968 MEDTRONIC VASCULAR MEDTRONIC MODEL 4016 BIPOLAR ENDOCARDIAL SCREW-IN 08/29/1985
K852356 MEDTRONIC VASCULAR MEDTRONIC MODEL 5561 08/06/1985
K844687 MEDTRONIC VASCULAR MEDTRONIC MODEL 6912 02/01/1985
K982220 MEDTRONIC VASCULAR MODEL 2872 BIPOLAR LEAD ADAPTOR KIT 10/15/1998
K911048 MEDTRONIC VASCULAR MODEL 5857-3M LEAD END CAP KIT 04/18/1991
K811349 MEDTRONIC VASCULAR MODEL 5866-24 LEAD ADAPTOR KIT 06/30/1981
K820935 MEDTRONIC VASCULAR MODEL 5866-26 LEAD ADAPTER KIT 04/16/1982
K900627 MEDTRONIC VASCULAR MODEL 5866-34 LEAD ADAPTOR KIT 04/20/1990
K904575 MEDTRONIC VASCULAR MODEL 5866-37M LEAD ADAPTOR KIT 02/01/1991
K915724 MEDTRONIC VASCULAR MODEL 6984M LEAD EXTENDER KIT 02/18/1992
K910630 MEDTRONIC VASCULAR MODEL 6985M TEMPORARY UNIPOLAR LEAD EXTENDER KIT 04/18/1991
K911302 MEDTRONIC VASCULAR MODELS 5866-24M/5866-38M/5866-40M/6986M ADAPT KIT 07/30/1991
K000210 MEDTRONIC VASCULAR MODIFICATION TO MODEL 5866-37M LEAD ADAPTOR KIT 02/23/2000
K842145 MEDTRONIC VASCULAR TRANSVENOUS TINED VENTRICULAR LEAD 01/18/1985
K911827 METRONIC, INC. MODEL 5866-9M & MODEL 6981M 07/23/1991
K143463 Oscor Inc. IS4/DF4 Port Plug 03/19/2015
K031164 Oscor Inc. PACING LEAD ADAPTORS, BIPOLAR, MODELS ILINK-BIS, ILINK-BLV 06/19/2003
K010787 Oscor Inc. PACING LEAD BIPOLAR ADAPTERS AND EXTENSIONS 05/22/2001
K024156 Oscor Inc. PACING LEAD EXTENSIONS, BIPOLAR, PACING LEAD ADAPTORS, UNIPOLAR/BIPOLAR,PACING LEAD ADAPTORS, UNIPOLAR/BIPOLAR 01/14/2003
K925168 OSCOR MEDICAL CORP. MISCELLANEOUS PACING LEAD 05/03/1994
K771642 PACESETTER SYSTEMS ADAPTER A-413 09/14/1977
K813154 PACESETTER SYSTEMS ADAPTING SLEEVE 12/02/1981
K790218 PACESETTER SYSTEMS BIPOLAR LEAD ADAPTOR, MODEL BA-415 08/10/1979
K813152 PACESETTER SYSTEMS ELECTRODE TERMINAL CAP 12/02/1981
K841885 PACESETTER SYSTEMS FASTPASS IMPLANTABLE ENDOCARDIAL PAC 08/03/1984
K841739 PACESETTER SYSTEMS MODEL 866 PERMATHANE BIPOLAR, COAXIAL 08/03/1984
K821549 PACESETTER SYSTEMS PACEMAKER 445 ADAPTER 06/02/1982
K821548 PACESETTER SYSTEMS PACEMAKER CONNECTOR PLUG 06/02/1982
K810551 PACESETTER SYSTEMS PACEMAKER LEAD ADAPTER 04/23/1981
K802407 PACESETTER SYSTEMS PACEMAKER LEAD ADAPTOR MODEL 431 10/31/1980
K821547 PACESETTER SYSTEMS PACEMAKER UNIPOLAR ADAPTER 06/02/1982
K850576 PACESETTER SYSTEMS PACESETTER SYS, ENDOCARDIAL, VENTRICULAR, BIPOLAR 03/06/1985
K851145 PACESETTER SYSTEMS PACESETTER SYSTEMS INC. ENDOCARDIAL FINNED LEAD 04/19/1985
K850652 PACESETTER SYSTEMS PACESETTER SYSTEMS, ENDOCARDIAL FIRM LEAD 04/10/1985
K844857 PACESETTER SYSTEMS PACESETTER SYSTEMS, INC. ENDOCARDIAL SCREW-IN LEAD 02/14/1985
K851665 PACESETTER SYSTEMS PACESETTER SYSTEMS, MODEL 458 ADAPTER SLEEVE 05/21/1985
K843703 PACESETTER SYSTEMS PERMATHANE 865 & 867 UNIPOLAR POLYURETH 01/08/1985
K900512 PACESETTER SYSTEMS SIEMENS ELEMA MODELS 4020T AND 4021T ADAPTERS 06/25/1990
K771641 PACESETTER SYSTEMS UNIVERSAL LEAD ADAPTER, UA-414 09/14/1977
K813151 PACESETTER SYSTEMS VITATRON INSERT 12/02/1981
K950140 PACESETTER, INC. IS-1/QUADRIPOLAR TERMINAL CAP, PART NUMBER 6011069 04/06/1995
K900605 POSSIS MEDICAL, INC. 3.2-5MM UNIPOLAR LEAD UPSIZING KIT, MODEL AK 100 03/06/1990
K781622 R.E. BROWN CO., INC. PACING LEAD ADAPTER MODEL ACS 16 12/08/1978
K781627 R.E. BROWN CO., INC. PACING LEAD ADAPTER MODEL ADB 21 12/08/1978
K781626 R.E. BROWN CO., INC. PACING LEAD ADAPTER, ACV 14, ACV 23 12/08/1978
K841227 SIEMENS ELEMA AB BIPOLAR ENDOCARDIAL LEAD 406L 11/27/1984
K921318 SIEMENS-PACESETTER, INC. ADAPTING SLEEVE KIT MODEL 4023 08/03/1992
K934899 TELECTRONICS PACING SYSTEMS, INC. BIFURCATED LEAD ADAPTORS, 3.2MM & 5.0 MM 05/12/1994
K910112 TELECTRONICS PACING SYSTEMS, INC. BIFURCATED VS-1 TO VS-1 LEAD ADAPTOR 02/25/1991
K895971 TELECTRONICS PACING SYSTEMS, INC. TELECTRONICS PACING SYSTEMS VS-1 TO 6MM UPSIZING 02/22/1990
K912773 TELECTRONICS PACING SYSTEMS, INC. UNIPOLAR UPSIZING ADAPTOR 10/23/1991
K896438 TELECTRONICS PACING SYSTEMS, INC. UPSIZING LEAD ADAPTERS 5.0MM PEEL-AWAY ADAPTER 04/10/1990
K782097 TELECTRONICS, INC. ELECTRODE LEAD MODEL 030-198 12/22/1978
K781822 TELECTRONICS, INC. ELECTRODE, MODEL 030-324 02/08/1979
K781824 TELECTRONICS, INC. ELECTRODE, MODEL 030-324/4 GUAGE 02/08/1979
K781823 TELECTRONICS, INC. ELECTRODE, MODEL 030-326 02/08/1979
K890895 TELECTRONICS, INC. IMPLANTABLE ADAPTOR 033-380 03/06/1990
K854997 TELECTRONICS, INC. IMPLANTABLE ELECTRODE ADAPTOR ASSEMBLY 02/12/1986
K840025 TELECTRONICS, INC. IMPLANTABLE ELECTRODE BIPOLAR ADAPT 05/23/1984
K840026 TELECTRONICS, INC. IMPLANTABLE ELECTRODE UNIPOLAR ADAPT 05/23/1984


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