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
337–360 of 461
Cleared Jan 24, 1979
ISOLATION SLEEVE, MODEL 346-01
K790101
Intermedics, Inc.
Cardiovascular · 8d
Cleared Dec 27, 1978
PACEMAKER, MODEL DDP ELECTRONIC CIRCUIT
K782146
Arco Medical Products Co.
Cardiovascular
Cleared Dec 22, 1978
MICROLITH A MODEL 703
K782022
Cardiac Pacemakers, Inc.
Cardiovascular · 17d
Cleared Dec 22, 1978
MICROLITH A MODEL 803
K782023
Cardiac Pacemakers, Inc.
Cardiovascular · 17d
Cleared Dec 07, 1978
PACEMAKER, MODEL 229-01
K781738
Intermedics, Inc.
Cardiovascular · 51d
Cleared Dec 06, 1978
GENERATOR, PULSE, SORIN MODEL DL-1
K780897
Bentley Laboratories, Inc.
Cardiovascular · 188d
Cleared Oct 03, 1978
ARCOBIOLITH PACEMAKER MODEL
K780776
Arco Medical Products Co.
Cardiovascular · 148d
Cleared Oct 03, 1978
GENERATORS, PULSE, MODELS 5988/5989
K781208
Medtronic Vascular
Cardiovascular · 81d
Cleared Oct 03, 1978
GENERATOR, PULSE, MODEL 5997
K781252
Medtronic Vascular
Cardiovascular · 74d
Cleared Sep 27, 1978
PACEMAKER, MODEL 225 & 227
K772226
Intermedics, Inc.
Cardiovascular · 295d
Cleared Sep 27, 1978
GENERATOR, PULSE, MODEL 160B
K780940
Telectronics, Inc.
Cardiovascular · 111d
Cleared Sep 27, 1978
GENERATORS: UDL-201B, BDL-201B, MDL-201B
K781424
Pacesetter Systems
Cardiovascular · 41d
Cleared Sep 07, 1978
GENERATOR, CARDIAC PULSE, 250B
K781090
Telectronics, Inc.
Cardiovascular · 66d
Cleared Sep 07, 1978
CARDIAL PULSE GENERATORS
K781426
Telectronics, Inc.
Cardiovascular · 16d
Cleared Aug 31, 1978
GENERATOR, PULSE, PACEMAKER
K781168
Vitatron Medical BV
Cardiovascular · 49d
Cleared Jul 28, 1978
GENERATOR, PULSE, DEMAND, MODEL 5996
K780741
Medtronic Vascular
Cardiovascular · 88d
Cleared Jul 28, 1978
GENERATOR, PULSE MODELS 5920/5921
K780809
Medtronic Vascular
Cardiovascular · 71d
Cleared Jul 27, 1978
GENERATOR, PULSE, CARDIAC, IMPLANTABLE
K780420
Telectronics, Inc.
Cardiovascular · 134d
Cleared Jul 27, 1978
VENTRICULAR INHIBITED PULSE GENERATOR
K780561
Medtronic Vascular
Cardiovascular · 111d
Cleared Jul 07, 1978
GENERATOR, PULSE, CARDIAC, IMPLANTABLE
K780421
Telectronics, Inc.
Cardiovascular · 114d
Cleared Jun 30, 1978
STANICOR THETA MODEL 221 CARDIAC PACER
K780453
Cordis Corp.
Cardiovascular · 102d
Cleared May 18, 1978
GENERATORS, ATRIAL INHIBITED PULSE
K780327
Medtronic Vascular
Cardiovascular · 80d
Cleared May 16, 1978
BAGS, PLASTIC, STERILE FOR GENERATORS
K780777
Telectronics, Inc.
Cardiovascular · 12d
Cleared Apr 05, 1978
PACEMAKER, MODEL 252, C-MOS
K780437
Intermedics, Inc.
Cardiovascular · 16d