DXY · Class III · 21 CFR 870.3610

FDA Product Code DXY: Implantable Pacemaker Pulse-generator

Leading manufacturers include Medtronic Vascular, Intermedics, Inc. and Telectronics, Inc..

461
Total
461
Cleared
80d
Avg days
1976
Since
461 devices
361–384 of 461
Cleared Feb 13, 1978
CARDIAC PULSE GENERATOR, MODEL 160B
K780113
Telectronics, Inc.
Cardiovascular · 25d
Cleared Jan 30, 1978
TDL-100 B
K772050
Pacesetter Systems
Cardiovascular · 91d
Cleared Jan 30, 1978
MDL-201
K772051
Pacesetter Systems
Cardiovascular · 91d
Cleared Jan 30, 1978
PULSE GENERATOR, UNIPOLAR, PROGRAMABLE
K772238
Cardiac Pacemakers, Inc.
Cardiovascular · 53d
Cleared Jan 30, 1978
PULSE GENERATOR, BIPOLAR, PROGRAMMABLE
K772239
Cardiac Pacemakers, Inc.
Cardiovascular · 53d
Cleared Jan 30, 1978
PULSE GENERATOR, UNIPOLAR, DEMAND
K772240
Cardiac Pacemakers, Inc.
Cardiovascular · 53d
Cleared Jan 30, 1978
PULSE GENERATOR, BIPOLAR, DEMAND
K772241
Cardiac Pacemakers, Inc.
Cardiovascular · 53d
Cleared Jan 30, 1978
CARDIAC PACER, MODEL 208
K780066
Cordis Corp.
Cardiovascular · 18d
Cleared Jan 24, 1978
PULSE GENERATORS, MODELS 5972/5973
K780061
Medtronic Vascular
Cardiovascular · 13d
Cleared Jan 17, 1978
PULSE GENERATORS
K772357
Medtronic Vascular
Cardiovascular · 21d
Cleared Jan 04, 1978
XYREL-RA MODELS 5994/5995
K771770
Medtronic Vascular
Cardiovascular · 107d
Cleared Jan 04, 1978
CARDIAC PULSE GENERATORS 5982/5983
K771786
Medtronic Vascular
Cardiovascular · 105d
Cleared Dec 20, 1977
PULSE GENERATOR, A-V SEQ.
K772202
Medtronic Vascular
Cardiovascular · 20d
Cleared Nov 28, 1977
CARDIAC PACEMAKER S6001
K772009
Vitatron Medical BV
Cardiovascular · 34d
Cleared Nov 28, 1977
CARDIAC PACEMAKER C2001
K772010
Vitatron Medical BV
Cardiovascular · 34d
Cleared Nov 03, 1977
CARDIAC PULSE GENERATOR, MODEL 150L
K772026
Telectronics, Inc.
Cardiovascular · 7d
Cleared Nov 03, 1977
BIPOLAR PACEMAKER MODEL 224
K772057
Intermedics, Inc.
Cardiovascular · 3d
Cleared Sep 12, 1977
PACEMAKER MODEL 251
K771626
Intermedics, Inc.
Cardiovascular · 18d
Cleared Sep 12, 1977
IMPLANTED PACEMAKER PLUSE GENERATOR
K771670
Telectronics, Inc.
Cardiovascular · 11d
Cleared Jul 21, 1977
PACEMAKER & CARDIAC LEAD, BIPOLAR
K771262
Arco Medical Products Co.
Cardiovascular · 10d
Cleared Jun 20, 1977
GENERATOR, PULSE, UNIPOLAR, #508
K770880
Cardiac Pacemakers, Inc.
Cardiovascular · 35d
Cleared Jun 20, 1977
GENERATOR, PULSE, BIPOLAR 3608
K770881
Cardiac Pacemakers, Inc.
Cardiovascular · 35d
Cleared Jun 20, 1977
CARDIAC PACERS W/NARROW PULSE WIDTH
K770951
Cordis Corp.
Cardiovascular · 26d
Cleared Apr 26, 1977
GENERATOR, PULSE, UNIPOLAR, MODEL #504
K770716
Cardiac Pacemakers, Inc.
Cardiovascular · 8d