FDA product code DTJ: Holder, Heart-Valve, Prosthesis
DTJ is the FDA product code for holder, heart-valve, prosthesis. It is a Class I device, regulated under 21 CFR 870.3935 and reviewed by the Cardiovascular panel. FDA has cleared 12 510(k) submissions under DTJ, from 7 different applicants. The average 510(k) review took 53 days (median 40). FDA has posted 1 recall for DTJ devices.
Classification
| Field | Value |
|---|---|
| Device name | Holder, Heart-Valve, Prosthesis |
| Device class | Class I |
| Regulation | 21 CFR 870.3935 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every DTJ clearance
Top DTJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Carbomedics, Inc. | 3 | 1996-08-27 |
| Shiley, Inc. | 2 | 1987-06-15 |
| Vascor, Inc. | 2 | 1981-05-13 |
| Edwards Laboratories | 2 | 1979-12-07 |
| Baxter Edwards | 1 | 1995-02-10 |
2 more applicants have DTJ clearances. See the full list in Caduvo.
Most recent DTJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K962154 | Carbomedics, Inc. | CARBOMEDICS HANDLE | 1996-08-27 | 84 |
| K960169 | Carbomedics, Inc. | CARBOMEDICS VALVE TESTER | 1996-04-15 | 90 |
| K944214 | Baxter Edwards | BAXTER HANDLE MODEL 1150 | 1995-02-10 | 165 |
| K942736 | Carbomedics, Inc. | CARBOMEDICS(R) PROSTHETIC HEART VALVE HOLDER HANDLE | 1994-07-06 | 26 |
| K880052 | Baxter Healthcare Corp | EDWARDS-DUROMEDICS MITRAL VALVE ROTATOR | 1988-04-01 | 86 |
Recalls for DTJ devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2002-04-30.
Frequently asked questions
What is FDA product code DTJ?
DTJ is the FDA product code for holder, heart-valve, prosthesis. It is a Class I device, regulated under 21 CFR 870.3935 and reviewed by the Cardiovascular panel.
What device class is DTJ?
Class I, regulation 21 CFR 870.3935. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code DTJ?
Across 12 cleared submissions the average was 53 days from receipt to decision (median 40).
Which companies have the most DTJ clearances?
Carbomedics, Inc. (3); Shiley, Inc. (2); Vascor, Inc. (2); Edwards Laboratories (2); Baxter Edwards (1).
Have DTJ devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2002-04-30.
Next steps
- Run an FDA pathway report with predicate devices for product code DTJ
- Run a recall and safety report across every DTJ manufacturer
- Watch product code DTJ 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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