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
49–72 of 487
Cleared Dec 03, 1992
MEDTRONIC MODELS 5069 AND 5071 MYOCARDIAL PACING
K915736
Medtronic Vascular
Cardiovascular · 349d
Cleared May 22, 1992
MODELS 6917T, 6917AT & 4951M EPICARDIAL PACE LEADS
K921124
Medtronic Vascular
Cardiovascular · 102d
Cleared Feb 11, 1992
PERMANENT CARDIAC PACING LEADS AND ADAPTORS
K912464
Medtronic Vascular
Cardiovascular · 252d
Cleared Oct 17, 1991
MEDTRONIC UNIPOLAR, POLY PAC LEAD-BARR COAT COILS
K913288
Medtronic Vascular
Cardiovascular · 85d
Cleared Sep 18, 1991
MODELS 432-03 & 433-03 IMPLANT ENDOCARD PAC LEAD
K912235
Intermedics, Inc.
Cardiovascular · 127d
Cleared Aug 28, 1991
ENDOCARDIAL LEADS-MOD. TO THE POLYVINYLPYRROLIDONE
K910924
Pacesetter Systems
Cardiovascular · 176d
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 Jul 17, 1990
FOCUS J81F, J83F, J41F, J43F PACING LEADS
K896742
Ela Medical, Inc.
Cardiovascular · 229d
Cleared Jul 17, 1990
ENDOCARDIAL SCREW-IN LEAD MODEL 1028T
K902147
Pacesetter Systems
Cardiovascular · 63d
Cleared May 03, 1990
MODIFIED UNIPOLAR IMPLANT. PACING LEADS W/IS-1
K900984
Medtronic Vascular
Cardiovascular · 63d
Cleared Apr 20, 1990
FAST-PASS ACE MODELS 1212T/1222T/1216T/1226T
K900550
Pacesetter Systems
Cardiovascular · 73d
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 Jan 18, 1990
FIVE-YEAR STERILE PACKAGING SHELF LIFE
K892528
Daig Corp.
Cardiovascular · 282d
Cleared Dec 20, 1989
ENDOCARDIAL SCREW-IN LEAD MODEL 1020T
K895447
Pacesetter Systems
Cardiovascular · 103d
Cleared Jul 14, 1989
IMPLANTABLE PACING LEADS W/IS-1 CONN., UNIPOLAR
K894040
Medtronic Vascular
Cardiovascular · 38d
Cleared Jun 20, 1989
PACEMAKER LEAD ADAPTER
K890018
Ela Medical, Inc.
Cardiovascular · 168d
Cleared Jun 05, 1989
CARDIOVASCULAR PERMANENT PACEMAKER ELECTRODE
K891905
Pacesetter Systems
Cardiovascular · 70d
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 Apr 19, 1989
HEPARIN BONDING FOR CATHETERS
K884697
Daig Corp.
Cardiovascular · 161d
Cleared Mar 28, 1989
MODELS 432-03 & 433-03 IMPLANTABLE PACING LEADS
K890411
Intermedics, Inc.
Cardiovascular · 63d