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
217–240 of 461
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 27, 1980
VIVALITH 5, - MDL-201A & TDL-201A
K801763
Pacesetter Systems
Cardiovascular · 30d
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 30, 1980
MICROTHIN-P1 (MOD. 0622)
K801121
Cardiac Pacemakers, Inc.
Cardiovascular · 49d
Cleared Jun 30, 1980
MICROTHIN-D1 (MOD. 0620)
K801122
Cardiac Pacemakers, Inc.
Cardiovascular · 49d
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 May 02, 1980
PULSE GENERATORS MODELS 657 & 677
K800387
Siemens Elema AB
Cardiovascular · 70d
Cleared Apr 24, 1980
MODEL 253-11 CYBERLITH PULSE GENERATOR
K800895
Intermedics, Inc.
Cardiovascular · 3d
Cleared Apr 16, 1980
NOMOS-01 PULSE GENERATOR
K800375
Biotronik Sales, Inc.
Cardiovascular · 55d
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 Mar 25, 1980
IMPLANTABLE PROGRAMMABLE BIPOLAR CARDIAC
K800573
Telectronics, Inc.
Cardiovascular · 11d
Cleared Feb 05, 1980
PULSE GENERATOR, MODEL NO. LIT 222
K792526
Bentley Laboratories, Inc.
Cardiovascular · 60d
Cleared Feb 05, 1980
SORIN PULSE GENERATOR MODEL # LIT 214 H
K792565
Bentley Laboratories, Inc.
Cardiovascular · 60d
Cleared Jan 31, 1980
MICROTHIN-DI
K800026
Cardiac Pacemakers, Inc.
Cardiovascular · 24d
Cleared Jan 31, 1980
MICROTHIN-PI
K800027
Cardiac Pacemakers, Inc.
Cardiovascular · 24d
Cleared Jan 11, 1980
IMPLANTABLE BIPOLAR CARDIAC PULSE GEN.
K800030
Telectronics, Inc.
Cardiovascular · 4d
Cleared Dec 20, 1979
IMPLANTABLE PROGRAMMABLE UNIPOLAR
K792519
Telectronics, Inc.
Cardiovascular · 14d
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 Oct 22, 1979
IMPLANTABLE PROGRAMMABLE UNIPOLAR CARD
K792052
Telectronics, Inc.
Cardiovascular · 7d