FDA product code DTG: Magnet, Test, Pacemaker
DTG is the FDA product code for magnet, test, pacemaker. It is a Class I device, regulated under 21 CFR 870.3690 and reviewed by the Cardiovascular panel. FDA has cleared 5 510(k) submissions under DTG, from 5 different applicants. The average 510(k) review took 166 days (median 90).
Classification
| Field | Value |
|---|---|
| Device name | Magnet, Test, Pacemaker |
| Device class | Class I |
| Regulation | 21 CFR 870.3690 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every DTG clearance
Top DTG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cyberonics, Inc. | 1 | 2009-11-03 |
| Cardiac Assist Devices, Inc. | 1 | 1997-03-26 |
| Cardiac Control Systems, Inc. | 1 | 1989-09-26 |
| Oscor, Inc. | 1 | 1984-03-12 |
| Pacesetter Systems | 1 | 1981-12-02 |
Most recent DTG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K092364 | Cyberonics, Inc. | MODEL 220 PATIENT MAGNET | 2009-11-03 | 90 |
| K960849 | Cardiac Assist Devices, Inc. | MAGNO ALARM | 1997-03-26 | 400 |
| K895110 | Cardiac Control Systems, Inc. | MAESTRO PACEMAKER TEST MAGNET | 1989-09-26 | 42 |
| K831926 | Oscor, Inc. | IMPLANTABLE ENDOCARDIAL PACING LEADS | 1984-03-12 | 271 |
| K813153 | Pacesetter Systems | TEST MAGNET | 1981-12-02 | 26 |
Recalls for DTG devices
openFDA lists no recalls for product code DTG.
Frequently asked questions
What is FDA product code DTG?
DTG is the FDA product code for magnet, test, pacemaker. It is a Class I device, regulated under 21 CFR 870.3690 and reviewed by the Cardiovascular panel.
What device class is DTG?
Class I, regulation 21 CFR 870.3690. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code DTG?
Across 5 cleared submissions the average was 166 days from receipt to decision (median 90).
Which companies have the most DTG clearances?
Cyberonics, Inc. (1); Cardiac Assist Devices, Inc. (1); Cardiac Control Systems, Inc. (1); Oscor, Inc. (1); Pacesetter Systems (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DTG
- Run a recall and safety report across every DTG manufacturer
- Watch product code DTG 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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