DTD · Class II · 21 CFR 870.3620

FDA Product Code DTD: Pacemaker Lead Adaptor

Leading manufacturers include Pacesetter Systems, Medtronic Vascular and Intermedics, Inc..

103
Total
101
Cleared
86d
Avg days
1977
Since

FDA 510(k) Cleared Pacemaker Lead Adaptor Devices (Product Code DTD)

103 devices
1–24 of 103
Cleared Mar 19, 2015
IS4/DF4 Port Plug
K143463
Oscor, Inc.
Cardiovascular · 105d
Cleared Jul 30, 2013
6981M LEAD EXTENDER KIT, 6984M LEAD EXTENDER KIT, 6986M LEAD EXTENDER KIT, 5866-24M LEAD ADAPTOR KIT, 5866-38M LEAD ADAP
K132008
Medtronic, Inc.
Cardiovascular · 29d
Cleared Jul 12, 2004
CPI LEAD ADAPTERS, MODELS 6017, 6018 AND 6020
K041574
Guidant Corporation
Cardiovascular · 28d
Cleared Jun 19, 2003
PACING LEAD ADAPTORS, BIPOLAR, MODELS ILINK-BIS, ILINK-BLV
K031164
Oscor, Inc.
Cardiovascular · 66d
Cleared Jan 14, 2003
PACING LEAD EXTENSIONS, BIPOLAR, PACING LEAD ADAPTORS, UNIPOLAR/BIPOLAR,PACING LEAD ADAPTORS, UNIPOLAR/BIPOLAR
K024156
Oscor, Inc.
Cardiovascular · 28d
Cleared May 22, 2001
PACING LEAD BIPOLAR ADAPTERS AND EXTENSIONS
K010787
Oscor, Inc.
Cardiovascular · 68d
Cleared Jan 18, 2001
A1-CS-SB Y-ADAPTER, MODEL 124 871
K003454
Biotronik, Inc.
Cardiovascular · 72d
Cleared Feb 23, 2000
MODIFICATION TO MODEL 5866-37M LEAD ADAPTOR KIT
K000210
Medtronic Vascular
Cardiovascular · 30d
Cleared Oct 15, 1998
MODEL 2872 BIPOLAR LEAD ADAPTOR KIT
K982220
Medtronic Vascular
Cardiovascular · 113d
Not Cleared Aug 14, 1997
A1-A,ABP,B,MBP, LEAD CONNECTORS
K970388
Biotronik, Inc.
Cardiovascular · 192d
Not Cleared Aug 14, 1997
BK-N SEALING CAP
K971930
Biotronik, Inc.
Cardiovascular · 79d
Cleared Apr 29, 1997
BK-A
K970204
Biotronik, Inc.
Cardiovascular · 98d
Cleared May 12, 1994
BIFURCATED LEAD ADAPTORS, 3.2MM & 5.0 MM
K934899
Telectronics Pacing Systems, Inc.
Cardiovascular · 210d
Cleared May 03, 1994
MISCELLANEOUS PACING LEAD
K925168
Oscor Medical Corp.
Cardiovascular · 567d
Cleared Feb 18, 1992
MODEL 6984M LEAD EXTENDER KIT
K915724
Medtronic Vascular
Cardiovascular · 60d
Cleared Oct 23, 1991
UNIPOLAR UPSIZING ADAPTOR
K912773
Telectronics Pacing Systems, Inc.
Cardiovascular · 121d
Cleared Aug 09, 1991
LEAD TERMINAL PIN CAPS, VARIOUS MODELS
K911142
Biotronik, GmbH & Co.
Cardiovascular · 148d
Cleared Jul 30, 1991
MODELS 5866-24M/5866-38M/5866-40M/6986M ADAPT KIT
K911302
Medtronic Vascular
Cardiovascular · 127d
Cleared Apr 18, 1991
MODEL 6985M TEMPORARY UNIPOLAR LEAD EXTENDER KIT
K910630
Medtronic Vascular
Cardiovascular · 64d
Cleared Apr 18, 1991
MODEL 5857-3M LEAD END CAP KIT
K911048
Medtronic Vascular
Cardiovascular · 41d
Cleared Feb 25, 1991
BIFURCATED VS-1 TO VS-1 LEAD ADAPTOR
K910112
Telectronics Pacing Systems, Inc.
Cardiovascular · 46d
Cleared Feb 01, 1991
MODEL 5866-37M LEAD ADAPTOR KIT
K904575
Medtronic Vascular
Cardiovascular · 115d
Cleared Aug 23, 1990
A1-A,A1-B,A1-ABP,A1-MBP,A1-Z,A6-A,A6-B,PEH PACE.
K902889
Biotronik, GmbH & Co.
Cardiovascular · 52d
Cleared Jun 25, 1990
SIEMENS ELEMA MODELS 4020T AND 4021T ADAPTERS
K900512
Pacesetter Systems
Cardiovascular · 143d

About Product Code DTD - Regulatory Context