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

Analyzer, Pacemaker Generator Function

21 CFR 870.3630 / Cardiovascular
FDA source (opens on fda.gov)

DTC is the FDA product code for Analyzer, Pacemaker Generator Function, a class II device type, regulated under 21 CFR 870.3630. As of , FDA records hold 30 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
DTC
Device name
Analyzer, Pacemaker Generator Function
Regulation
21 CFR 870.3630
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
30
Ingested recalls
0

Clearances, product code DTC

By decision year
30 clearances under product code DTC with a decision year between 1976 and 2017, 1978 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code DTC by decision year
YearClearances
19761
19772
19783
19792
19803
19811
19821
19841
19853
19861
19881
19892
19901
19913
19961
20001
20011
20091
20171

Applicants with the most clearances

Product code DTC
Applicants holding the most 510(k) clearances under product code DTC
ApplicantClearances
Medtronic, Inc.5
Seamed Corp.4
Instromedix, Inc.3
BIOTRONIK AG2
Cordis US Corp.2
Ela Medical, Inc.2
Adcor Electronics, Inc.1
Bio-Tek Instruments, Inc.1
Boston Scientific Corporation1
Dart Medical Equipment1

Companies listing this code with FDA

Companies whose registered establishments list this code