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
313–336 of 487
Cleared Apr 16, 1982
IMPLANTIBLE SUTURE SLEEVE
K820487
Intermedics, Inc.
Cardiovascular · 52d
Cleared Apr 09, 1982
BIOPOLAR TINED ENDOCARDIAL LEAD 403B/60
K820767
Siemens Elema AB
Cardiovascular · 18d
Cleared Feb 12, 1982
LASERPOR AP ATRIAL ENDOCARD. ELECTR. LD.
K820121
Telectronics, Inc.
Cardiovascular · 25d
Cleared Jan 28, 1982
INTERSEPT CARDIOTOMY RESERVOIR/FILTER
K813205
Extracorporeal Medical Specialities, Inc.
Cardiovascular · 76d
Cleared Dec 10, 1981
POLY-FLEX PACING LEADS
K813028
Intermedics, Inc.
Cardiovascular · 43d
Cleared Dec 10, 1981
ATRIAL ENDOCARDIAL ELECTRODE LEAD J-TIP
K813134
Telectronics, Inc.
Cardiovascular · 35d
Cleared Nov 27, 1981
ELECTRODE, PACEMAKER, PERMANENT
K810139
Pacesetter Systems
Cardiovascular · 310d
Cleared Nov 27, 1981
PACEPATH IMPLANT. ENDOCARD. PACING LEAD
K810286
Pacesetter Systems
Cardiovascular · 298d
Cleared Nov 16, 1981
INTERMEDICS POLYFLEX-MODEL 493-03 LEAD
K812989
Intermedics, Inc.
Cardiovascular · 21d
Cleared Nov 16, 1981
INTERMEDICS POLYFLEX-MODEL 483-03 LEAD
K812990
Intermedics, Inc.
Cardiovascular · 21d
Cleared Nov 16, 1981
INTERMEDICS POLYFLEX-MODEL 483-04 LEAD
K812991
Intermedics, Inc.
Cardiovascular · 21d
Cleared Oct 29, 1981
MODEL 833 ENDOCARDIAL TINED LEAD
K812815
Pacesetter Systems
Cardiovascular · 22d
Cleared Oct 29, 1981
MODEL 841 ENDOCARDIAL TINED LEAD
K812816
Pacesetter Systems
Cardiovascular · 22d
Cleared Oct 23, 1981
MEDTRONIC #4951
K812599
Medtronic Vascular
Cardiovascular · 39d
Cleared Oct 13, 1981
ATRIAL ENDOCARDIAL ELECTRODE LEAD OF J
K811593
Telectronics, Inc.
Cardiovascular · 127d
Cleared Oct 06, 1981
INTERMEDICS POLY FLEX EPICARDIAL SUTURE
K812221
Intermedics, Inc.
Cardiovascular · 60d
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 Aug 03, 1981
MODEL D BIPOLAR ENDOCARDIAL LEAD
K811876
Cook Pacemaker Corp.
Cardiovascular · 33d
Cleared Aug 03, 1981
MODEL C UNIPOLAR ENDOCARDIAL LEAD
K811877
Cook Pacemaker Corp.
Cardiovascular · 33d
Cleared Aug 03, 1981
MODEL B BIPOLAR ENDOCARDIAL LEAD
K811878
Cook Pacemaker Corp.
Cardiovascular · 33d
Cleared Aug 03, 1981
MODEL A UNIPOLAR ENDOCARDIAL LEAD
K811879
Cook Pacemaker Corp.
Cardiovascular · 33d
Cleared Jul 02, 1981
ENDOCARDIAL ELECTRODE
K810928
Vitatron Medical BV
Cardiovascular · 87d