DXY · Class III · 21 CFR 870.3610

FDA Product Code DXY: Implantable Pacemaker Pulse-generator

Leading manufacturers include Medtronic Vascular, Intermedics, Inc. and Cordis Corp..

461
Total
461
Cleared
80d
Avg days
1976
Since
461 devices
73–96 of 461
Cleared Sep 16, 1981
MEDTRONIC ENERTRAX MODEL 7100
K812096
Medtronic Vascular
Cardiovascular · 54d
Cleared Aug 31, 1981
MEDTRONIC SPECTRAX
K812153
Medtronic Vascular
Cardiovascular · 33d
Cleared Jul 20, 1981
CORDIS OMNI-ARTICOR CARDIAC PACER #308
K811691
Cordis Corp.
Cardiovascular · 35d
Cleared Jul 01, 1981
UNIPOLAR SPECTRAX IMPL. PULSE GENERAT.
K811350
Medtronic Vascular
Cardiovascular · 49d
Cleared May 27, 1981
MEDTRONIC PULSE GENERATOR
K811123
Medtronic Vascular
Cardiovascular · 33d
Cleared May 27, 1981
INTERMEDICS CYBERLITH BIPOLAR CARDIAC
K811221
Intermedics, Inc.
Cardiovascular · 23d
Cleared May 15, 1981
MODELS 8420 THRU 8423 PACEMAKER GENER
K810734
Medtronic Vascular
Cardiovascular · 58d
Cleared May 01, 1981
THINLITH III UNIPOLAR CARDIAC PULSE GEN.
K810752
Intermedics, Inc.
Cardiovascular · 42d
Cleared May 01, 1981
MODEL 230-05 CYBERLITH I BIPOL. PULSE G.
K810800
Intermedics, Inc.
Cardiovascular · 39d
Cleared May 01, 1981
MODEL 230-06 CYBERLITH TM I BIPOLAR IN
K811066
Intermedics, Inc.
Cardiovascular · 14d
Cleared Apr 14, 1981
INSULATIVE COATING FOR CARD. PULSE GEN
K810901
Intermedics, Inc.
Cardiovascular · 11d
Cleared Apr 01, 1981
INTERMEDICS CYBERLITH I BIOPOLAR CARDI
K810383
Intermedics, Inc.
Cardiovascular · 47d
Cleared Apr 01, 1981
CYBERLITH I PULSE GENERATOR MODEL 253-04
K810385
Intermedics, Inc.
Cardiovascular · 47d
Cleared Mar 13, 1981
THINLITH II PULSE GNEERATOR MODEL 227-05
K810386
Intermedics, Inc.
Cardiovascular · 28d
Cleared Feb 12, 1981
MULTI-PROGRAMMABLE PACEMAKER & PROGRMR.
K801584
Medtronic Vascular
Cardiovascular · 216d
Cleared Jan 07, 1981
CYBERLITH PROGRAMMER
K801338
Intermedics, Inc.
Cardiovascular · 217d
Cleared Sep 09, 1980
MEDTRONIC MODEL 2409
K800226
Medtronic Vascular
Cardiovascular · 217d
Cleared Sep 09, 1980
INSULATING SHEATH
K801910
Cordis Corp.
Cardiovascular · 29d
Cleared Sep 09, 1980
BATTERY FOR #229-01 PULSE GENERATOR
K802040
Intermedics, Inc.
Cardiovascular · 29d
Cleared Aug 14, 1980
INTERMEDICS THIN LITH IV SERIES UNIPOLAR
K801450
Intermedics, Inc.
Cardiovascular · 55d
Cleared Jul 08, 1980
MULTICOR (GAMMA) MODEL 336 & MODEL 337
K801106
Cordis Corp.
Cardiovascular · 60d
Cleared Jun 26, 1980
MEDTRONIC MODELS 5966/5967, ETC.
K800069
Medtronic Vascular
Cardiovascular · 167d
Cleared May 20, 1980
MODEL 5985 PACEMAKER PULSE GENERATOR
K800285
Medtronic Vascular
Cardiovascular · 102d
Cleared Apr 24, 1980
MODEL 253-11 CYBERLITH PULSE GENERATOR
K800895
Intermedics, Inc.
Cardiovascular · 3d