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
265–288 of 461
Cleared Oct 31, 1980
MICROTHIN-DI BIPOLAR PULSE GENERATOR
K802409
Cardiac Pacemakers, Inc.
Cardiovascular · 28d
Cleared Oct 31, 1980
MICROTHIN-PI BIPOLAR PULSE GENERATOR
K802410
Cardiac Pacemakers, Inc.
Cardiovascular · 28d
Cleared Oct 03, 1980
SORIN PULSE GENERATOR, MODEL #LIT-214
K801640
Bentley Laboratories, Inc.
Cardiovascular · 78d
Cleared Sep 26, 1980
PROGRAMALITH #'S 221, 222, 221A & 222A
K801978
Pacesetter Systems
Cardiovascular · 38d
Cleared Sep 26, 1980
IMPLANTABLE VENTRICULAR-INHIB. C.P. GEN
K802028
Telectronics, Inc.
Cardiovascular · 36d
Cleared Sep 18, 1980
IMPLANTABLE PROGRAM. CARDIAC PACEMAKER
K800793
Telectronics, Inc.
Cardiovascular · 162d
Cleared Sep 16, 1980
SIEMENS-ELEMA PULSE GENERATOR 625
K801508
Siemens Elema AB
Cardiovascular · 78d
Cleared Sep 09, 1980
MEDTRONIC MODEL 2409
K800226
Medtronic Vascular
Cardiovascular · 217d
Cleared Sep 09, 1980
EXTERNAL SILASTIC BOOT FOR CARDIAC PULSE
K801806
Arco Medical Products Co.
Cardiovascular · 41d
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
PROGRAMMABLE BIPOLAR CARDIAC GENERATOR
K800837
Arco Medical Products Co.
Cardiovascular · 76d
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 30, 1980
UNIPOLAR PROGRAMMABLE LITHIUM CARD. GEN.
K801241
Arco Medical Products Co.
Cardiovascular · 34d
Cleared Jun 26, 1980
MEDTRONIC MODELS 5966/5967, ETC.
K800069
Medtronic Vascular
Cardiovascular · 167d
Cleared Jun 04, 1980
ARCOLITH 3022&ARCOLITH 3023 CARDIAC GEN.
K800838
Arco Medical Products Co.
Cardiovascular · 50d
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