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

FDA 510(k) Number Applicant Device Name Decision Date
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
K041574 GUIDANT CORPORATION CPI LEAD ADAPTERS, MODELS 6017, 6018 AND 6020 07/12/2004
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
K982220 MEDTRONIC VASCULAR MODEL 2872 BIPOLAR LEAD ADAPTOR KIT 10/15/1998
K000210 MEDTRONIC VASCULAR MODIFICATION TO MODEL 5866-37M LEAD ADAPTOR KIT 02/23/2000
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


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