510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DTAClass II

Tester, Pacemaker Electrode Function

21 CFR 870.3720 / Cardiovascular
FDA source (opens on fda.gov)

DTA is the FDA product code for Tester, Pacemaker Electrode Function, a class II device type, regulated under 21 CFR 870.3720. As of , FDA records hold 10 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
DTA
Device name
Tester, Pacemaker Electrode Function
Regulation
21 CFR 870.3720
Device class
Class II
Review panel
Cardiovascular
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
10
Ingested recalls
2

Clearances, product code DTA

By decision year
10 clearances under product code DTA with a decision year between 1979 and 2017, 1979 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code DTA by decision year
YearClearances
19792
19811
19931
20032
20051
20071
20101
20171

Applicants with the most clearances

Product code DTA
Applicants holding the most 510(k) clearances under product code DTA
ApplicantClearances
BIOTRONIK AG3
Cardiac Pacemakers, Inc.1
Ep Medical, Inc.1
Medtronic, Inc.1
Remington Medical1
Siemens Corp.1
Abbott Medical1
Vitatron Medical BV1

Companies listing this code with FDA

Companies whose registered establishments list this code