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

FDA 510(k) Cleared Permanent Pacemaker Electrode Devices (Product Code DTB)

487 devices
1–24 of 487
Cleared Jul 10, 2006
BIOTRONIK ENDOCARDIAL PACING LEADS
K061212
Biotronik, Inc.
Cardiovascular · 70d
Cleared Aug 06, 2004
PERMANENT PACING LEAD, MODEL PY2
K041809
Oscor, Inc.
Cardiovascular · 31d
Cleared Apr 07, 2004
PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJU
K040569
Oscor, Inc.
Cardiovascular · 34d
Cleared May 22, 2003
MODEL 5071 MYOCARDIAL PACING LEAD
K031274
Medtronic Vascular
Cardiovascular · 30d
Cleared Apr 24, 2003
ELOX P 45-BP
K023205
Biotronik, Inc.
Cardiovascular · 211d
Cleared Jan 31, 2003
PERMANENT PACING LEADS, MODELS PHYSIQUE PB AND PJB
K024053
Oscor, Inc.
Cardiovascular · 53d
Cleared Dec 11, 2002
MODIFICATION TO BIOTRONIK'S STERILIZATION PROCESS
K023803
Biotronik, Inc.
Cardiovascular · 27d
Cleared Oct 18, 2002
AROX 45-JBP
K023099
Biotronik, Inc.
Cardiovascular · 30d
Cleared May 01, 2002
AROX 53-BP
K021217
Biotronik, Inc.
Cardiovascular · 14d
Cleared Apr 09, 2002
MEROX BIPOLAR HIGH IMPEDANCE LEAD MODELS: MEX 53/13-BP
K010281
Biotronik, Inc.
Cardiovascular · 434d
Cleared Mar 28, 2002
PERMANENT PACING LEAD, MODELS PETITE, PETITE R, J, RJ, PETITE B, RB, JB, RJB
K020669
Oscor, Inc.
Cardiovascular · 27d
Cleared Nov 08, 2001
PERMANENT PACING LEAD W/POLARIS COATED TIPS, VARIOUS MODELS
K013339
Oscor, Inc.
Cardiovascular · 30d
Cleared May 22, 2001
OSCOR PERMANENT PACING LEAD RZ MODEL SERIES
K003918
Oscor, Inc.
Cardiovascular · 154d
Cleared Jan 09, 2001
PACING LEADS, GUIDE WIRES, AND VARIOUS ACCESSORIES
K003072
Biotronik, Inc.
Cardiovascular · 98d
Cleared Jun 02, 2000
ELOX 45-BP, MODEL 330 132, EFH-27, MODEL 331 549, EXTENSION TOOL, MODEL 331 668
K001413
Biotronik, Inc.
Cardiovascular · 29d
Cleared Apr 13, 2000
EX 45-BP, MODEL 330 132
K994240
Biotronik, Inc.
Cardiovascular · 119d
Cleared Apr 10, 2000
STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHAPED TINED PACING LEADS
K993448
Ela Medical, Inc.
Cardiovascular · 181d
Cleared Apr 04, 2000
STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHAPED TINED PACING LEADS
K000029
Ela Medical, Inc.
Cardiovascular · 90d
Cleared Dec 17, 1999
YP 45/15-BP
K993139
Biotronik, Inc.
Cardiovascular · 88d
Cleared Jul 01, 1999
SX 53/15-BP, MODEL 124 853, SX 60/15-BP, MODEL 124 854
K991169
Biotronik, Inc.
Cardiovascular · 85d
Cleared Jun 03, 1999
RETROX RX 45-JBP 124774, 53-JBP 124775, 53-BP 124776, 60-124777
K990483
Biotronik, Inc.
Cardiovascular · 107d
Cleared Sep 10, 1998
SYNOX SX 53-BP, SX 60-BP, SX 45-JBP, SX 53-JBP , MODELS 120 444, 119 684, 120 438 AND 120 143
K980869
Biotronik, Inc.
Cardiovascular · 188d
Cleared Jul 22, 1998
RETROX RX 53-BP, RETROX RX 60-BP, RETROX RX 45-JBP, RETROX RX 53-JBP MODEL NUMBERS 124 396, 124 397, 124 395, 124 000
K981083
Biotronik, Inc.
Cardiovascular · 120d
Not Cleared Mar 04, 1998
TIR/TIJ AND POLYROX
K972500
Biotronik, Inc.
Cardiovascular · 244d

About Product Code DTB - Regulatory Context