DTB · Class III · 21 CFR 870.3680

FDA Product Code DTB: Permanent Pacemaker Electrode

Leading manufacturers include Intermedics, Inc., Medtronic Vascular and Telectronics, Inc..

487
Total
479
Cleared
119d
Avg days
1976
Since
487 devices
73–96 of 487
Cleared Mar 28, 1989
MODELS 430-07 & 431-07 IMPLANTABLE PACING LEADS
K890412
Intermedics, Inc.
Cardiovascular · 63d
Cleared Mar 22, 1989
SIEMENS ELEMA MODELS 4025 AND 4026 ADAPTERS
K890547
Pacesetter Systems
Cardiovascular · 47d
Cleared Feb 02, 1989
VS-1 SILICONE IMPLANT LEADS (NEW SERIAL # TUBE)
K890350
Telectronics, Inc.
Cardiovascular · 86d
Cleared Jan 30, 1989
MODEL 6208,6209,6210,6211,6212,6214 (PLI'S)
K890045
Medtronic Vascular
Cardiovascular · 25d
Cleared Jan 17, 1989
MEDTRONIC MODEL 4058 PACING LEAD
K883743
Medtronic Vascular
Cardiovascular · 138d
Cleared Dec 15, 1988
IMPLANTABLE ELECTRODE LEADS 033-400,402 AND 436
K884278
Telectronics, Inc.
Cardiovascular · 64d
Cleared Dec 08, 1988
PACING LEADS FOCUS T81,T81F,T82F,T83,T83F,T84F
K884394
Ela Medical, Inc.
Cardiovascular · 55d
Cleared Dec 05, 1988
ENDOCARDIAL PACING LEADS-ANCHORING SLEEVE MODIFIED
K884005
Medtronic Vascular
Cardiovascular · 75d
Cleared Oct 13, 1988
MEDTRONIC MODEL 4951P
K881810
Medtronic Vascular
Cardiovascular · 168d
Cleared Sep 06, 1988
MODEL 5866-34A PACEMAKER LEAD ADAPTOR
K883203
Medtronic Vascular
Cardiovascular · 40d
Cleared Sep 06, 1988
BIOPORE VS.1 ENDOCARDIAL INTER IMPLANT PACING LEAD
K883602
Intermedics, Inc.
Cardiovascular · 14d
Cleared Aug 25, 1988
MEDTRONIC MODELS 4057/4557 ENDOCARDIAL PACING LEAD
K882452
Medtronic Vascular
Cardiovascular · 72d
Cleared May 31, 1988
IMPLANTABLE ELECTRODE LEAD, MODEL 030-446
K874664
Telectronics, Inc.
Cardiovascular · 200d
Cleared May 25, 1988
MODEL 435-04 CARDIFIX SIDE HOOK IMPLANT. PACE LEAD
K875178
Intermedics, Inc.
Cardiovascular · 160d
Cleared May 25, 1988
MEDTRONIC MODEL 5866-36 LEAD ADAPTOR KIT
K881712
Medtronic Vascular
Cardiovascular · 34d
Cleared May 24, 1988
MODEL 438-03 CARDIFIX SIDE HOOK IMPLANT. PACE LEAD
K875100
Intermedics, Inc.
Cardiovascular · 166d
Cleared Mar 22, 1988
MODEL 438-02 CARDIFIX SIDE HOOK IMPLANT. PACE LEAD
K872126
Intermedics, Inc.
Cardiovascular · 294d
Cleared Mar 07, 1988
MODEL 439-07 AND 439-09 LIFELINE MYOCARDIAL LEAD
K880551
Intermedics, Inc.
Cardiovascular · 27d
Cleared Feb 18, 1988
NP BIPOLAR ENDOCARDIAL LEAD W/VS-1 CONNECTOR
K875199
Biotronik Sales, Inc.
Cardiovascular · 62d
Cleared Feb 02, 1988
MEDTRONIC MODEL 4016A ENDOCARDIAL PACING LEAD
K873962
Medtronic Vascular
Cardiovascular · 126d
Cleared Feb 02, 1988
ENDOCARDIAL SCREW-IN LEAD, MODEL 1018T
K874205
Pacesetter Systems
Cardiovascular · 110d
Cleared Jan 29, 1988
ACTIFIX (R) BIPOLAR ENDOCARDIAL SCREW-IN LEAD
K874183
Daig Corp.
Cardiovascular · 108d
Cleared Jan 19, 1988
MODEL 5013 TRANSVENOUS VENTRICULAR PACING LEAD
K874792
Medtronic Vascular
Cardiovascular · 60d
Cleared Jan 07, 1988
POLYFLEX(R) EPICARDIAL 439-04 IMPLANT PACING LEAD
K874531
Intermedics, Inc.
Cardiovascular · 65d