DTE · Class II · 21 CFR 870.3600

FDA Product Code DTE: Pulse-generator, Pacemaker, External

Leading manufacturers include Seamed Corp., Pace Medical and Medtronic, Inc..

65
Total
65
Cleared
111d
Avg days
1978
Since
65 devices
49–65 of 65
Cleared Dec 16, 1983
EXTERNAL PULSE GENERATOR FOR TEMP. STIM
K831768
Oscor, Inc.
Cardiovascular · 198d
Cleared Aug 31, 1983
RAPID ATRIAL PACER
K831381
Seamed Corp.
Cardiovascular · 125d
Cleared Dec 15, 1982
SEA MED MODEL 880
K823048
Seamed Corp.
Cardiovascular · 61d
Cleared Jul 06, 1982
EXTERNAL PULSE GENERATOR - EV4542
K821791
American Pacemaker Corp.
Cardiovascular · 19d
Cleared Jun 03, 1982
SEAMED, #540 - SIEMENS, #146F TELECTRO
K820570
Seamed Corp.
Cardiovascular · 93d
Cleared Jul 01, 1981
STERILE PACKAGING
K811092
Telectronics, Inc.
Cardiovascular · 71d
Cleared Apr 01, 1981
SIEMENS MODEL 146-146A EXTERNAL PULSE G
K810566
Cynergy
Cardiovascular · 29d
Cleared Feb 23, 1981
PACING SYSTEM ANALYZER
K803313
Medtronic Vascular
Cardiovascular · 54d
Cleared Nov 19, 1980
CHRONOCOR IV MODEL 250
K802221
Cordis Corp.
Cardiovascular · 68d
Cleared Oct 31, 1980
COMPUPACE, 524-01 PACER SYSTEM COMPUTER
K801055
Intermedics, Inc.
Cardiovascular · 178d
Cleared Oct 23, 1980
EXTERNAL, TEMP. PORTABLE CARDIAC GENER
K801953
Telectronics, Inc.
Cardiovascular · 66d
Cleared Sep 16, 1980
CYNERGY MODEL 184
K801596
Cynergy
Cardiovascular · 64d
Cleared Jan 29, 1980
PACEMAKER ELECTRODE INSERTER AIDE
K800088
Telectronics, Inc.
Cardiovascular · 15d
Cleared Nov 30, 1979
PACESETTER MODEL 350
K792223
Cynergy
Cardiovascular · 25d
Cleared Dec 29, 1978
MEDTRONIC MODEL 546
K782108
Medtronic Vascular
Cardiovascular · 10d
Cleared Dec 11, 1978
PULSE GENERATOR, MODEL 240, EXTERNAL
K781327
Intermedics, Inc.
Cardiovascular · 132d