FDA product code DTF: Tools, Pacemaker Service
DTF is the FDA product code for tools, pacemaker service. It is a Class I device, regulated under 21 CFR 870.3730 and reviewed by the Cardiovascular panel. FDA has cleared 2 510(k) submissions under DTF, from 2 different applicants. The average 510(k) review took 28 days (median 28).
Classification
| Field | Value |
|---|---|
| Device name | Tools, Pacemaker Service |
| Device class | Class I |
| Regulation | 21 CFR 870.3730 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every DTF clearance
Top DTF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cardiac Pacemakers, Inc. | 1 | 1988-01-27 |
| Telectronics, Inc. | 1 | 1978-07-27 |
Most recent DTF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K875147 | Cardiac Pacemakers, Inc. | TORQUE HEX WRENCH | 1988-01-27 | 43 |
| K781179 | Telectronics, Inc. | WRENCH, GEXAGON, DRIVER | 1978-07-27 | 13 |
Recalls for DTF devices
openFDA lists no recalls for product code DTF.
Frequently asked questions
What is FDA product code DTF?
DTF is the FDA product code for tools, pacemaker service. It is a Class I device, regulated under 21 CFR 870.3730 and reviewed by the Cardiovascular panel.
What device class is DTF?
Class I, regulation 21 CFR 870.3730. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code DTF?
Across 2 cleared submissions the average was 28 days from receipt to decision (median 28).
Which companies have the most DTF clearances?
Cardiac Pacemakers, Inc. (1); Telectronics, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DTF
- Run a recall and safety report across every DTF manufacturer
- Watch product code DTF for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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