DTB · Class III · 21 CFR 870.3680

FDA Product Code DTB: Permanent Pacemaker Electrode

Leading manufacturers include Medtronic Vascular, Intermedics, Inc. and Cordis Corp..

487
Total
479
Cleared
119d
Avg days
1976
Since
487 devices
49–72 of 487
Cleared Feb 02, 1988
MEDTRONIC MODEL 4016A ENDOCARDIAL PACING LEAD
K873962
Medtronic Vascular
Cardiovascular · 126d
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
Cleared Jan 06, 1988
MODEL 366-12 ADAPTAID(TM) STEP-DOWN ADAPTER
K874930
Intermedics, Inc.
Cardiovascular · 35d
Cleared Dec 07, 1987
MEDTRONIC PERMANENT LEAD INTRODUCER
K874167
Medtronic Vascular
Cardiovascular · 55d
Cleared Dec 03, 1987
MODEL 366-30 ADAPTAID(TM) ADAPTER SLEEVE
K873921
Intermedics, Inc.
Cardiovascular · 69d
Cleared Nov 06, 1987
MEDTRONIC MODEL 5513 ENDOCARDIAL PACING LEAD
K870885
Medtronic Vascular
Cardiovascular · 246d
Cleared May 22, 1987
IMPLANTABLE PACING LEAD MODELS 487-06 TO 430-01
K871580
Intermedics, Inc.
Cardiovascular · 29d
Cleared May 21, 1987
ELECTRODE, PACEMAKER, PERMANENT & TEMPORARY
K870357
Intermedics, Inc.
Cardiovascular · 112d
Cleared May 21, 1987
MODEL 366-12 ADAPTAID (TM) STEP-DOWN ADAPTER
K871625
Intermedics, Inc.
Cardiovascular · 24d
Cleared May 06, 1987
IMPLANTABLE TINED, TRANS. PACING LEAD/REVIS. LABEL
K871333
Medtronic Vascular
Cardiovascular · 33d
Cleared Apr 10, 1987
MODEL 435-03 SIDE HOOK IMPLANTABLE PACING LEAD
K870948
Intermedics, Inc.
Cardiovascular · 32d
Cleared Jan 16, 1987
MODEL 366-13 ADAPTAID STEP DOWN ADAPTER
K864326
Intermedics, Inc.
Cardiovascular · 73d
Cleared Jan 06, 1987
MODEL 436-01 BIOPORE IMPLANTABLE PACING LEAD
K862051
Intermedics, Inc.
Cardiovascular · 222d
Cleared Jan 06, 1987
MEDTRONIC MODEL 5013
K863536
Medtronic Vascular
Cardiovascular · 117d
Cleared Jan 06, 1987
ANCOR PERVENOUS ACTIVE FIXATION UNIPOLAR LEAD
K864640
Cordis Corp.
Cardiovascular · 41d
Cleared Jan 06, 1987
MODEL 366-14 INTERMEDICS LEAD CONNECTOR CAP
K864738
Intermedics, Inc.
Cardiovascular · 33d
Cleared Jan 06, 1987
MODEL 5866-24 PACEMAKER LEAD ADAPTOR
K864856
Medtronic Vascular
Cardiovascular · 26d
Cleared Dec 05, 1986
MODEL 366-23 ADAPTAID(TM) STEP-DOWN ADAPTER
K864428
Intermedics, Inc.
Cardiovascular · 23d
Cleared Dec 05, 1986
MODEL 486-05 POLYFLEX(R) IMPLANTABLE PACING LEAD
K864564
Intermedics, Inc.
Cardiovascular · 16d
Cleared Nov 20, 1986
MODEL 431-06 POLYFLEX IMPLANTABLE PACING LEAD
K864002
Intermedics, Inc.
Cardiovascular · 37d
Cleared Nov 20, 1986
MODEL 430-05 POLYFLEX IMPLANTABLE PACING LEAD
K864287
Intermedics, Inc.
Cardiovascular · 21d
Cleared Nov 03, 1986
MODEL 493-08 POLYFLEX ENDOCARDIAL LEAD
K863781
Intermedics, Inc.
Cardiovascular · 38d
Cleared Nov 03, 1986
MODEL 366-28 ADAPTAID(TM) STEP-DOWN ADAPTER
K864047
Intermedics, Inc.
Cardiovascular · 18d