DTC · Class II · 21 CFR 870.3630

FDA Product Code DTC: Analyzer, Pacemaker Generator Function

Leading manufacturers include Medtronic Vascular, Seamed Corp. and Instromedix, 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 Oct 10, 2000
MODEL 4810 ANALYZER OUTPUT ADAPTER
K002497
Pace Medical
Cardiovascular · 57d
Cleared Nov 08, 1996
EXTERNAL PACEMAKER ANALYZER, MODEL PMT 100
K961582
North American Technical Services Corp.
Cardiovascular · 198d
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 Mar 19, 1991
CPI MODEL 2215/SEAMED MODEL 3400
K910223
Seamed Corp.
Cardiovascular · 60d
Cleared May 09, 1990
PK-55 ANDOVER MEDICAL PART #5455 LABEL CHANGE
K901332
Biotronik, GmbH & Co.
Cardiovascular · 48d
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 Oct 06, 1988
PACER SENSING ANALYZER (PSA 100)
K882327
Oscor Medical Corp.
Cardiovascular · 122d
Cleared Aug 19, 1986
SEAMED MODEL 3000
K860462
Seamed Corp.
Cardiovascular · 194d
Cleared Jul 19, 1985
SEA MED DDD PACING SYSTEM ANALYZER
K851900
Seamed Corp.
Cardiovascular · 80d
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 Sep 04, 1984
TELECTRONICS MODEL 2401
K831697
Seamed Corp.
Cardiovascular · 468d
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 Sep 21, 1979
SELF CHECK
K791762
Instromedix, Inc.
Cardiovascular · 24d
Cleared Aug 31, 1978
PACER-TRACER PULSE WIDTH
K781349
Instromedix, Inc.
Cardiovascular · 24d
Cleared Jun 30, 1978
EXTERNAL TEST PULSE GENERATOR
K780717
Vitatron Medical BV
Cardiovascular · 64d

About Product Code DTC - Regulatory Context