DTC · Class II · 21 CFR 870.3630

FDA Product Code DTC: Analyzer, Pacemaker Generator Function

Leading manufacturers include Medtronic Vascular, Cordis Corp. and Boston Scientific Corporation.

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 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 Jul 20, 1976
PACER SYSTEMS ANALYZER (CORDIS)
K760013
Cordis Corp.
Cardiovascular · 40d

About Product Code DTC - Regulatory Context