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
145–168 of 487
Cleared May 07, 1986
DJ UNIPOLAR
K853566
Biotronik Sales, Inc.
Cardiovascular · 254d
Cleared May 07, 1986
DJP UNIPOLAR
K853567
Biotronik Sales, Inc.
Cardiovascular · 254d
Cleared Apr 29, 1986
MODEL 366-20 ADAPTAID STEP-DOWN ADAPTER
K861176
Intermedics, Inc.
Cardiovascular · 29d
Cleared Apr 23, 1986
MODEL 366-10 ADAPTAID STEP-DOWN ADAPTER
K861110
Intermedics, Inc.
Cardiovascular · 29d
Cleared Mar 31, 1986
MODEL 366-19 ADAPTAID ADAPTER SLEEVE
K860985
Intermedics, Inc.
Cardiovascular · 14d
Cleared Mar 31, 1986
MODEL 366-09 ADAPTAID ADAPTER SLEEVE
K860986
Intermedics, Inc.
Cardiovascular · 14d
Cleared Mar 11, 1986
MODEL 435-01 CARDIFIX IMPLANTABLE PACING LEAD
K854917
Intermedics, Inc.
Cardiovascular · 92d
Cleared Mar 11, 1986
MODEL 431-01 BIOPORE IMPLANTABLE PACING LEAD
K854918
Intermedics, Inc.
Cardiovascular · 92d
Cleared Jan 15, 1986
DNR UNIPOLAR
K853568
Biotronik Sales, Inc.
Cardiovascular · 142d
Cleared Jan 15, 1986
STYLET INTRODUCER FUNNEL
K854142
Telectronics, Inc.
Cardiovascular · 96d
Cleared Jan 13, 1986
MOD TARGET/TIPS # 4011,4012,4511,4512,6912,4016
K854582
Medtronic Vascular
Cardiovascular · 59d
Cleared Dec 09, 1985
POLYFLEX 483-09 ENDOCARDIAL IMPLANTABLE PACINGLEAD
K854069
Intermedics, Inc.
Cardiovascular · 66d
Cleared Dec 04, 1985
IMPLANT ELECT LEAD MOD 30-404 USING POLYU 90 A
K852710
Telectronics, Inc.
Cardiovascular · 161d
Cleared Dec 04, 1985
MEDTRONIC MODEL 5062
K853398
Medtronic Vascular
Cardiovascular · 114d
Cleared Dec 04, 1985
LIFELINE ENDOCARDIAL UNIPOLAR LEAD 483-08
K853517
Intermedics, Inc.
Cardiovascular · 104d
Cleared Dec 04, 1985
POLYFLEX IMPLANTABLE PACING LEAD-476-07
K853521
Intermedics, Inc.
Cardiovascular · 104d
Cleared Dec 04, 1985
POLYFLEX 493-07 ENDOCARDIAL IMPLANTABLE PAC-LEAD
K854071
Intermedics, Inc.
Cardiovascular · 61d
Cleared Dec 04, 1985
PACESETTER SYSEMS ENDOCARDIAL TRI-FIX LEAD
K854220
Pacesetter Systems
Cardiovascular · 47d
Cleared Dec 04, 1985
PACESETTER SYSTEMS ENDOCARDIAL SMALL FIN LEAD
K854405
Pacesetter Systems
Cardiovascular · 33d
Cleared Dec 03, 1985
PACESETTER SYS FAST PASS ENDOCARDIAL LEAD 856 INLI
K853914
Pacesetter Systems
Cardiovascular · 71d
Cleared Nov 05, 1985
LIFELINE ENDOCARDIAL BIPOLAR LEAD 476-06
K853518
Intermedics, Inc.
Cardiovascular · 75d
Cleared Oct 24, 1985
LIFELINE ENDOCARDIAL BIPOLAR LEAD 484-03
K853519
Intermedics, Inc.
Cardiovascular · 63d
Cleared Oct 08, 1985
LIFELINE ENDOCARDIAL UNIPOLAR 487-06 TLE LEAD
K853520
Intermedics, Inc.
Cardiovascular · 47d
Cleared Oct 01, 1985
IMPLANT ELECT LEAD, MOD 030-405 USING POLYU 90 A
K852708
Telectronics, Inc.
Cardiovascular · 97d