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
25–48 of 65
Cleared May 19, 1993
EXTERNAL DEMAND PACEMAKER
K923621
Oscor Medical Corp.
Cardiovascular · 302d
Cleared Aug 14, 1992
CPI MODEL 2215
K923398
Seamed Corp.
Cardiovascular · 35d
Cleared Feb 07, 1992
CHRONOCOR VI MODEL 5012
K915364
Seamed Corp.
Cardiovascular · 72d
Cleared Nov 19, 1991
MINIATURE MODELS 4562/4563/4572/4573 PACEMAKER
K913805
Pace Medical
Cardiovascular · 85d
Cleared Sep 03, 1991
CPI MODEL 2215 & SEAMED MODEL 3400
K912507
Seamed Corp.
Cardiovascular · 89d
Cleared Feb 25, 1991
MODIFIED MODEL 5330 AV DEMAND PULSE GENERATOR
K910237
Medtronic Vascular
Cardiovascular · 38d
Cleared Jul 19, 1990
MODELS 4201, 4231 & 4235 EXTENSION CABLES
K902679
Pace Medical
Cardiovascular · 30d
Cleared Jan 24, 1990
MODEL EC4542G MINIATURE
K896352
Pace Medical
Cardiovascular · 79d
Cleared Jun 20, 1989
MODEL 5330 EXTERNAL A-V SEQUENTIAL DEMAND PULSE
K893633
Medtronic Vascular
Cardiovascular · 40d
Cleared Nov 09, 1988
SEAMED MODEL 3300 DUAL CHAMBER PACING SYSTEM ANALY
K883930
Seamed Corp.
Cardiovascular · 55d
Cleared Jul 31, 1987
SEAMED MODEL 3200
K872551
Seamed Corp.
Cardiovascular · 32d
Cleared Jun 10, 1987
MINIATURE TEMP. CARDIAC PACEMAKERS EC4542 & EC4543
K871915
Pace Medical
Cardiovascular · 23d
Cleared Mar 11, 1987
ERA-20
K853194
Biotronik Sales, Inc.
Cardiovascular · 589d
Cleared Mar 03, 1987
MODEL EV4543 MINIATURE TEMPORARY CARDIAC PACEMAKER
K870323
Pace Medical
Cardiovascular · 34d
Cleared Dec 10, 1986
SEA MED MODEL 6000
K863903
Seamed Corp.
Cardiovascular · 64d
Cleared Jan 16, 1986
SEAMED MODEL 4000
K854648
Seamed Corp.
Cardiovascular · 58d
Cleared Jul 16, 1985
CHRONOCOR V EXTERNAL PACER, MODEL 297A
K850822
Seamed Corp.
Cardiovascular · 138d
Cleared Feb 01, 1985
SEAMED 4000
K843777
Seamed Corp.
Cardiovascular · 129d
Cleared Feb 01, 1985
SEAMED MODEL 6000
K843807
Seamed Corp.
Cardiovascular · 127d
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 Jun 03, 1982
SEAMED, #540 - SIEMENS, #146F TELECTRO
K820570
Seamed Corp.
Cardiovascular · 93d
Cleared Jul 01, 1981
STERILE PACKAGING
K811092
Telectronics, Inc.
Cardiovascular · 71d