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
97–120 of 461
Cleared Apr 16, 1980
CYBERLITH IMPLANTABLE PULSE GEN. #253-02
K800644
Intermedics, Inc.
Cardiovascular · 23d
Cleared Apr 08, 1980
CYBERLITH IMPLANTABLE PULSE GEN. #253-04
K800645
Intermedics, Inc.
Cardiovascular · 15d
Cleared Nov 15, 1979
MEDTRONIC MODELS 5984/5985
K791316
Medtronic Vascular
Cardiovascular · 126d
Cleared Oct 22, 1979
OMNI-STANICOR (THETA) MOD 237A
K791783
Cordis Corp.
Cardiovascular · 41d
Cleared Sep 28, 1979
PULSE GENERATORS, MODELS 5983, 5989
K790068
Medtronic Vascular
Cardiovascular · 259d
Cleared Sep 28, 1979
CORDIS BIPOLAR PACER CONNECTOR SYSTEM
K791784
Cordis Corp.
Cardiovascular · 16d
Cleared Sep 20, 1979
PROGRAMMER, MEDTRONIC MODEL 5984/5985
K791181
Medtronic Vascular
Cardiovascular · 87d
Cleared Sep 19, 1979
IMPLANTABLE PULSE GENERATOR PACEMAKERS
K791568
Intermedics, Inc.
Cardiovascular · 40d
Cleared Sep 12, 1979
MODEL 228-02 THINLITH II PACEMAKER, BIPO
K791379
Intermedics, Inc.
Cardiovascular · 50d
Cleared Sep 04, 1979
IMPLANTABLE PULSE GENERATOR PACEMAKER
K791417
Intermedics, Inc.
Cardiovascular · 39d
Cleared Jun 20, 1979
MODELS 2411/2418 VENTRICULAR-INHIBITED
K791093
Medtronic Vascular
Cardiovascular · 8d
Cleared May 16, 1979
OMNI-STANICOR-(THETA) MODEL 217
K790690
Cordis Corp.
Cardiovascular · 36d
Cleared Feb 08, 1979
BIPOLAR, STANICOR LAMBDA MODEL 236,235
K790014
Cordis Corp.
Cardiovascular · 36d
Cleared Jan 24, 1979
ISOLATION SLEEVE, MODEL 349-01
K790098
Intermedics, Inc.
Cardiovascular · 8d
Cleared Jan 24, 1979
ISOLATION SLEEVE, MODEL 347-01
K790099
Intermedics, Inc.
Cardiovascular · 8d
Cleared Jan 24, 1979
ISOLATION SLEEVE, MODEL 348-01
K790100
Intermedics, Inc.
Cardiovascular · 8d
Cleared Jan 24, 1979
ISOLATION SLEEVE, MODEL 346-01
K790101
Intermedics, Inc.
Cardiovascular · 8d
Cleared Dec 07, 1978
PACEMAKER, MODEL 229-01
K781738
Intermedics, Inc.
Cardiovascular · 51d
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 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
VENTRICULAR INHIBITED PULSE GENERATOR
K780561
Medtronic Vascular
Cardiovascular · 111d