510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
DTFClass I

Tools, Pacemaker Service

21 CFR 870.3730 / Cardiovascular
FDA source (opens on fda.gov)

DTF is the FDA product code for Tools, Pacemaker Service, a class I device type, regulated under 21 CFR 870.3730. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
DTF
Device name
Tools, Pacemaker Service
Regulation
21 CFR 870.3730
Device class
Class I
Review panel
Cardiovascular
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code DTF

By decision year
2 clearances under product code DTF with a decision year between 1978 and 1988, 1978 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code DTF by decision year
YearClearances
19781
19881

Applicants with the most clearances

Product code DTF
Applicants holding the most 510(k) clearances under product code DTF
ApplicantClearances
Cardiac Pacemakers, Inc.1
Telectronics, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code