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
121–144 of 487
Cleared Nov 24, 1986
DAIG TYPE O4 VS-1 CONNECTOR
K863921
Daig Corp.
Cardiovascular · 47d
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
Cleared Nov 03, 1986
MODEL 366-27 ADAPTAID(TM) STEP-DOWN ADAPTER
K864048
Intermedics, Inc.
Cardiovascular · 17d
Cleared Sep 23, 1986
BIOTRONIK PERMANENT PACEMAKER ELECTRODE
K863480
Biotronik Sales, Inc.
Cardiovascular · 14d
Cleared Sep 19, 1986
MODEL 432-01 BIOPORE IMPLANTABLE PACING LEAD
K862053
Intermedics, Inc.
Cardiovascular · 113d
Cleared Sep 19, 1986
MODEL 430-01 BIOPORE IMPLANTABLE PACING LEAD
K862054
Intermedics, Inc.
Cardiovascular · 113d
Cleared Aug 05, 1986
CORDIS ANCOR ACTIVE FIXATION LEAD
K832422
Cordis Corp.
Cardiovascular · 1110d
Cleared Aug 05, 1986
CORDIS HI-FLEX PERVENOUS ACTIVE FIXATION UNIPOLAR
K851064
Cordis Corp.
Cardiovascular · 508d
Cleared Jul 18, 1986
IMPLANTABLE ELECTRODE LEAD, MODEL 030-436
K861767
Telectronics, Inc.
Cardiovascular · 72d
Cleared Jul 10, 1986
MODEL 431-02 BIOPORE IMPLANTABLE PACING LEAD
K862257
Intermedics, Inc.
Cardiovascular · 27d
Cleared Jul 10, 1986
MODEL 437-01 BIOPORE IMPLANTABLE PACING LEAD
K862258
Intermedics, Inc.
Cardiovascular · 27d
Cleared Jul 10, 1986
MODEL 433-01 BIOPORE IMPLANTABLE PACING LEAD
K862259
Intermedics, Inc.
Cardiovascular · 27d
Cleared Jul 10, 1986
MEDTRONIC TEMPORARY AND IMPLANTABLE PACING LEADS
K862443
Medtronic Vascular
Cardiovascular · 14d
Cleared Jul 03, 1986
MODEL 438-01 CARDIFIX IMPLANTABLE PACING LEAD
K862052
Intermedics, Inc.
Cardiovascular · 35d
Cleared Jul 02, 1986
MODEL 435-02 CARDIFIX IMPLANTABLE PACING LEAD
K862276
Intermedics, Inc.
Cardiovascular · 16d
Cleared Jun 26, 1986
CORDIS HI-FLEX PERVENOUS BIPOLAR LEAD
K860846
Cordis Corp.
Cardiovascular · 112d
Cleared Jun 13, 1986
MODEL 486-02 ENDOCARDIAL PACING LEAD
K860547
Intermedics, Inc.
Cardiovascular · 120d
Cleared Jun 13, 1986
MODEL 492-02 ENDOCARDIAL PACING LEAD
K860548
Intermedics, Inc.
Cardiovascular · 120d
Cleared Jun 06, 1986
ENDOCARDIAL CARBON-TIP LEAD
K861481
Pacesetter Systems
Cardiovascular · 45d
Cleared May 19, 1986
LEAD BODY CHANGES TO HI PERFORM & FAST-PASS LEADS
K861464
Pacesetter Systems
Cardiovascular · 28d
Cleared May 13, 1986
LEADS UTILIZ VOLUN STAND #1 3.2 MM UNI/BIOPOLAR CO
K861440
Pacesetter Systems
Cardiovascular · 26d