DTC · Class II · 21 CFR 870.3630

FDA Product Code DTC: Analyzer, Pacemaker Generator Function

Leading manufacturers include Medtronic Vascular, Cordis Corp. and Ela Medical, Inc..

30
Total
30
Cleared
109d
Avg days
1976
Since

FDA 510(k) Cleared Analyzer, Pacemaker Generator Function Devices (Product Code DTC)

30 devices
1–24 of 30
Cleared Jul 06, 2017
PSA Cable
K170815
Boston Scientific Corporation
Cardiovascular · 111d
Cleared Apr 01, 2009
PK-141 PATIENT CABLE
K083674
Biotronik, Inc.
Cardiovascular · 111d
Cleared Jun 19, 1991
EXTERNAL PACEMAKER ANALYZER MODEL PMA-1
K903966
Bio-Tek Instruments, Inc.
Cardiovascular · 295d
Cleared May 07, 1991
MODEL 5311B A-V PACING SYSTEM ANALYZER
K910595
Medtronic Vascular
Cardiovascular · 84d
Cleared Dec 13, 1989
MEDTRONIC MODEL 5401B TEST CABLE
K896632
Medtronic Vascular
Cardiovascular · 21d
Cleared Jan 10, 1989
MEDTRONIC MODEL 5311B A-V PACING SYSTEM ANALYZER
K884331
Medtronic Vascular
Cardiovascular · 88d
Cleared Jul 16, 1985
MEDTRONIC 5311 PACING SYSTEM ANALYZER
K850077
Medtronic Vascular
Cardiovascular · 188d
Cleared May 01, 1985
CORDIS DUAL-CHAMBER PSA MODEL 296A (PACEMAKER)
K844969
Cordis Corp.
Cardiovascular · 128d
Cleared Jun 17, 1982
MEDTRONIC A-V PACING SYSTEM ANALYZER
K812262
Medtronic Vascular
Cardiovascular · 308d
Cleared Apr 14, 1981
ELECTRODE/PACER SYSTEM ANALYZER PMA 400
K810604
Telectronics, Inc.
Cardiovascular · 39d
Cleared Mar 25, 1980
SUSI II PACEMAKER SURVEILLANCE MONITOR
K792602
Ela Medical, Inc.
Cardiovascular · 98d
Cleared Jan 31, 1980
PACING SYSTEM ANALYZER PSA SCE-22
K791975
Ela Medical, Inc.
Cardiovascular · 121d
Cleared Dec 27, 1979
MODEL 674 PACER ANALYZER
K792074
Del Mar Avionics
Cardiovascular · 73d
Cleared Jul 20, 1976
PACER SYSTEMS ANALYZER (CORDIS)
K760013
Cordis Corp.
Cardiovascular · 40d

About Product Code DTC - Regulatory Context