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
265–288 of 487
Cleared Oct 06, 1981
INTERMEDICS POLY FLEX ENDOCARDIAL ATRIAL
K812245
Intermedics, Inc.
Cardiovascular · 56d
Cleared Aug 13, 1981
PACEPATH IMPLANTABLE ENDOCARD. PACING LD
K811200
Pacesetter Systems
Cardiovascular · 105d
Cleared Aug 07, 1981
TYPE FH ENDOCARDIAL LEAD
K810494
Biotronik Sales, Inc.
Cardiovascular · 164d
Cleared Jul 01, 1981
CORDIS ENCOR PEWENOUS VENTRICULAR BIPOL
K811539
Cordis Corp.
Cardiovascular · 30d
Cleared May 27, 1981
INTERMEDICS POLY FLEX ENDOCARDIAL PACING
K811106
Intermedics, Inc.
Cardiovascular · 34d
Cleared Mar 20, 1981
TYPE YC ENDOCARDIAL LEAD
K810491
Biotronik Sales, Inc.
Cardiovascular · 24d
Cleared Mar 20, 1981
TYPE YR ENDOCARDIAL LEAD
K810492
Biotronik Sales, Inc.
Cardiovascular · 24d
Cleared Mar 20, 1981
TYPE N ENDOCARDIAL LEAD
K810493
Biotronik Sales, Inc.
Cardiovascular · 24d
Cleared Mar 13, 1981
TEMPORARY MYOCARDIAL PACING LEAD#6400
K810333
Medtronic Vascular
Cardiovascular · 32d
Cleared Mar 13, 1981
CORDIS PERVENOUS ATRIAL LEAD
K810432
Cordis Corp.
Cardiovascular · 22d
Cleared Mar 13, 1981
ELECTRODE, PACEMAKER PERMANENT
K810582
Pacesetter Systems
Cardiovascular · 10d
Cleared Feb 09, 1981
POLY FLEX IMPLANTABLE PACING LEAD
K802295
Intermedics, Inc.
Cardiovascular · 143d
Cleared Feb 05, 1981
CORDIS MULTIFILAR PERVENOUS VENTRIC. LD
K810202
Cordis Corp.
Cardiovascular · 13d
Cleared Jan 16, 1981
PERMANENT & TEMP. PACEMAKER ELECTRODE
K802547
Daig Corp.
Cardiovascular · 93d
Cleared Jan 16, 1981
PERM. ENDOCARDIAL UNIPOLAR TINED/WEDGE
K802552
Daig Corp.
Cardiovascular · 93d
Cleared Jan 16, 1981
PERM. ENDOCARDIAL UNIPOLAR WEDGE URETHAN
K802553
Daig Corp.
Cardiovascular · 93d
Cleared Jan 16, 1981
ENDOCARDIAL LEADS 414S & 515S
K802816
Siemens Elema AB
Cardiovascular · 70d
Cleared Jan 02, 1981
IMPLANT. ENDOCARDIAL DISH TIP ELECT. LDS
K802413
Telectronics, Inc.
Cardiovascular · 88d
Cleared Dec 22, 1980
UNIPOLAR ENDOCARDIAL LASER DRILLED ELEC
K802968
Telectronics, Inc.
Cardiovascular · 31d
Cleared Dec 22, 1980
SIEMENS-ELEMA ENDOCARDIAL LEAD 402S
K803042
Siemens Elema AB
Cardiovascular · 21d
Cleared Dec 01, 1980
INTERMEDICS' LIFELINE TLE ENDOCARDIAL
K801172
Intermedics, Inc.
Cardiovascular · 199d
Cleared Dec 01, 1980
LOW PROFILE LEAD CONNECTOR MODIFICATION (4002)
K801284
Medtronic Vascular
Cardiovascular · 186d
Cleared Nov 13, 1980
MEDTRONIC MODEL 6958
K800870
Medtronic Vascular
Cardiovascular · 210d
Cleared Oct 31, 1980
PACEPATH MODEL 810
K801416
Pacesetter Systems
Cardiovascular · 137d