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
97–120 of 487
Cleared Mar 06, 1990
MEDTRONIC IMPLANTABLE PACING LEADS W/IS-1 CONN.
K896313
Medtronic Vascular
Cardiovascular · 125d
Cleared Feb 08, 1990
PERMANENT AND TEMP. PACEMAKER ELECTRODE & LEAD ADA
K895136
Medtronic Vascular
Cardiovascular · 176d
Cleared Feb 05, 1990
MODIFIED J-STIFFENER WIRE MATERIAL IN LEAD LINES
K897067
Telectronics Pacing Systems, Inc.
Cardiovascular · 46d
Cleared Jan 18, 1990
FIVE-YEAR STERILE PACKAGING SHELF LIFE
K892528
Daig Corp.
Cardiovascular · 282d
Cleared Dec 20, 1989
ENDOCARDIAL SCREW-IN LEAD MODEL 1020T
K895447
Pacesetter Systems
Cardiovascular · 103d
Cleared Dec 20, 1989
MYOPORE(TM) UNIPOLAR MODELS 1117 & 1118 PACE LEADS
K896443
Possis Medical, Inc.
Cardiovascular · 41d
Cleared Nov 14, 1989
NEW ADHESIVE, PELLETHAN ON POLYURETHANE LEADS-MODI
K893041
Telectronics Pacing Systems, Inc.
Cardiovascular · 204d
Cleared Jul 14, 1989
MYOPORE(TM) UNIPOLAR SUTURELESS MYOCARDIAL LEADS
K885175
Possis Medical, Inc.
Cardiovascular · 212d
Cleared Jul 14, 1989
MODELS 1113 AND 1114 PACEMAKER LEADS
K893763
Possis Medical, Inc.
Cardiovascular · 56d
Cleared Jul 14, 1989
IMPLANTABLE PACING LEADS W/IS-1 CONN., UNIPOLAR
K894040
Medtronic Vascular
Cardiovascular · 38d
Cleared Jun 20, 1989
PACEMAKER LEAD ADAPTER
K890018
Ela Medical, Inc.
Cardiovascular · 168d
Cleared Jun 05, 1989
CARDIOVASCULAR PERMANENT PACEMAKER ELECTRODE
K891905
Pacesetter Systems
Cardiovascular · 70d
Cleared May 31, 1989
MEDTRONIC MODEL 5866-45 SIZING SLEEVE
K890644
Medtronic Vascular
Cardiovascular · 112d
Cleared Apr 21, 1989
ALTERNATE PACKAGING CONFIGURATION FOR PACING LEADS
K890527
Medtronic Vascular
Cardiovascular · 78d
Cleared Apr 19, 1989
HEPARIN BONDING FOR CATHETERS
K884697
Daig Corp.
Cardiovascular · 161d
Cleared Mar 28, 1989
MODELS 432-03 & 433-03 IMPLANTABLE PACING LEADS
K890411
Intermedics, Inc.
Cardiovascular · 63d
Cleared Mar 28, 1989
MODELS 430-07 & 431-07 IMPLANTABLE PACING LEADS
K890412
Intermedics, Inc.
Cardiovascular · 63d
Cleared Mar 22, 1989
SIEMENS ELEMA MODELS 4025 AND 4026 ADAPTERS
K890547
Pacesetter Systems
Cardiovascular · 47d
Cleared Feb 02, 1989
VS-1 SILICONE IMPLANT LEADS (NEW SERIAL # TUBE)
K890350
Telectronics, Inc.
Cardiovascular · 86d
Cleared Jan 30, 1989
MODEL 6208,6209,6210,6211,6212,6214 (PLI'S)
K890045
Medtronic Vascular
Cardiovascular · 25d
Cleared Jan 17, 1989
MEDTRONIC MODEL 4058 PACING LEAD
K883743
Medtronic Vascular
Cardiovascular · 138d
Cleared Dec 15, 1988
IMPLANTABLE ELECTRODE LEADS 033-400,402 AND 436
K884278
Telectronics, Inc.
Cardiovascular · 64d
Cleared Dec 08, 1988
PACING LEADS FOCUS T81,T81F,T82F,T83,T83F,T84F
K884394
Ela Medical, Inc.
Cardiovascular · 55d
Cleared Dec 05, 1988
ENDOCARDIAL PACING LEADS-ANCHORING SLEEVE MODIFIED
K884005
Medtronic Vascular
Cardiovascular · 75d