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 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 Jan 29, 1980
PACEMAKER ELECTRODE INSERTER AIDE
K800088
Telectronics, Inc.
Cardiovascular · 15d
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