DTB · Class III · 21 CFR 870.3680

FDA Product Code DTB: Permanent Pacemaker Electrode

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

487
Total
479
Cleared
119d
Avg days
1976
Since
487 devices
25–48 of 487
Cleared Sep 18, 1991
MODELS 432-03 & 433-03 IMPLANT ENDOCARD PAC LEAD
K912235
Intermedics, Inc.
Cardiovascular · 127d
Cleared Apr 22, 1991
INTERMEDICS MODEL 431-11 IMPLANT ENDOCARD PAC LEAD
K903948
Intermedics, Inc.
Cardiovascular · 238d
Cleared Mar 01, 1991
INTERMEDICS 430-07 BIPOL IMPLANT ENDOCARD PAC LEAD
K902672
Intermedics, Inc.
Cardiovascular · 256d
Cleared Sep 26, 1990
MODELS 5069/5071 MYOCARDIAL PACING LEADS
K902002
Medtronic Vascular
Cardiovascular · 147d
Cleared May 03, 1990
MODIFIED UNIPOLAR IMPLANT. PACING LEADS W/IS-1
K900984
Medtronic Vascular
Cardiovascular · 63d
Cleared Mar 06, 1990
MEDTRONIC IMPLANTABLE PACING LEADS W/IS-1 CONN.
K896313
Medtronic Vascular
Cardiovascular · 125d
Cleared Feb 08, 1990
PERMANENT AND TEMP. PACEMAKER ELECTRODE & LEAD ADA
K895136
Medtronic Vascular
Cardiovascular · 176d
Cleared Jul 14, 1989
IMPLANTABLE PACING LEADS W/IS-1 CONN., UNIPOLAR
K894040
Medtronic Vascular
Cardiovascular · 38d
Cleared May 31, 1989
MEDTRONIC MODEL 5866-45 SIZING SLEEVE
K890644
Medtronic Vascular
Cardiovascular · 112d
Cleared Apr 21, 1989
ALTERNATE PACKAGING CONFIGURATION FOR PACING LEADS
K890527
Medtronic Vascular
Cardiovascular · 78d
Cleared Mar 28, 1989
MODELS 432-03 & 433-03 IMPLANTABLE PACING LEADS
K890411
Intermedics, Inc.
Cardiovascular · 63d
Cleared Mar 28, 1989
MODELS 430-07 & 431-07 IMPLANTABLE PACING LEADS
K890412
Intermedics, Inc.
Cardiovascular · 63d
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 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 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