FDA product code DTC: Analyzer, Pacemaker Generator Function
DTC is the FDA product code for analyzer, pacemaker generator function. It is a Class II device, regulated under 21 CFR 870.3630 and reviewed by the Cardiovascular panel. FDA has cleared 30 510(k) submissions under DTC, from 19 different applicants. The average 510(k) review took 109 days (median 82).
Classification
| Field | Value |
|---|---|
| Device name | Analyzer, Pacemaker Generator Function |
| Device class | Class II |
| Regulation | 21 CFR 870.3630 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for DTC
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 111 |
Compare with all 510(k) review times · Search every DTC clearance
Top DTC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medtronic Vascular | 5 | 1991-05-07 |
| Seamed Corp. | 4 | 1991-03-19 |
| Instromedix, Inc. | 3 | 1979-09-21 |
| Cordis Corp. | 2 | 1985-05-01 |
| Ela Medical, Inc. | 2 | 1980-03-25 |
14 more applicants have DTC clearances. See the full list in Caduvo.
Most recent DTC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K170815 | Boston Scientific Corporation | PSA Cable | 2017-07-06 | 111 |
| K083674 | Biotronik, Inc. | PK-141 PATIENT CABLE | 2009-04-01 | 111 |
| K011729 | Dni Nevada, Inc. | SIGMA PACE EXTERNAL PACEMAKER ANALYZER MODEL #1000 | 2001-08-30 | 87 |
| K002497 | Pace Medical | MODEL 4810 ANALYZER OUTPUT ADAPTER | 2000-10-10 | 57 |
| K961582 | North American Technical Services Corp. | EXTERNAL PACEMAKER ANALYZER, MODEL PMT 100 | 1996-11-08 | 198 |
Recalls for DTC devices
openFDA lists no recalls for product code DTC.
Frequently asked questions
What is FDA product code DTC?
DTC is the FDA product code for analyzer, pacemaker generator function. It is a Class II device, regulated under 21 CFR 870.3630 and reviewed by the Cardiovascular panel.
What device class is DTC?
Class II, regulation 21 CFR 870.3630. Typical premarket route: 510(k).
How long does a 510(k) take for product code DTC?
Across 30 cleared submissions the average was 109 days from receipt to decision (median 82).
Which companies have the most DTC clearances?
Medtronic Vascular (5); Seamed Corp. (4); Instromedix, Inc. (3); Cordis Corp. (2); Ela Medical, Inc. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code DTC
- Run a recall and safety report across every DTC manufacturer
- Watch product code DTC 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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