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
193–216 of 487
Cleared Jun 24, 1986
S80 IMPLANTABLE CARDIAC PACING LEAD
K854963
Sorin Biomedica, Fiat, USA, Inc.
Cardiovascular · 195d
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
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 Feb 26, 1986
OSCOR MEDICAL UNIPOLAR PERMANENT PACING LEAD-CONNE
K854128
Oscor Medical Corp.
Cardiovascular · 140d
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
POLYSAFE CCS TRIFIX ENDOCARDIAL PACING LEAD SV-107
K853446
Cardiac Control Systems, Inc.
Cardiovascular · 150d
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
CCS MODEL BV-114 IMPLANTABLE ENDOCARDIAL BIPOLARPA
K853294
Cardiac Control Systems, Inc.
Cardiovascular · 110d
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