FDA product code DTI: Sizer, Heart-Valve, Prosthesis
DTI is the FDA product code for sizer, heart-valve, prosthesis. It is a Class I device, regulated under 21 CFR 870.3945 and reviewed by the Cardiovascular panel. FDA has cleared 7 510(k) submissions under DTI, from 6 different applicants. The average 510(k) review took 90 days (median 86). FDA has posted 2 recalls for DTI devices.
Classification
| Field | Value |
|---|---|
| Device name | Sizer, Heart-Valve, Prosthesis |
| Device class | Class I |
| Regulation | 21 CFR 870.3945 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every DTI clearance
Top DTI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Carbomedics, Inc. | 2 | 1995-11-29 |
| Baxter Healthcare Corp | 1 | 1988-05-18 |
| Hemex Scientific, Inc. | 1 | 1985-11-01 |
| Medtronic Vascular | 1 | 1985-09-23 |
| Celtech | 1 | 1982-07-08 |
1 more applicants have DTI clearances. See the full list in Caduvo.
Most recent DTI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K952184 | Carbomedics, Inc. | CARBOMEDICS SUPRA-ANNULAR VALVE SIZER | 1995-11-29 | 204 |
| K934951 | Carbomedics, Inc. | VALVE SIZER | 1993-12-10 | 53 |
| K881279 | Baxter Healthcare Corp | EDWARDS-DUROMEDICS BILEAFLET VALVE SIZER SET | 1988-05-18 | 57 |
| K853313 | Hemex Scientific, Inc. | DUROMEDICS CARDIAC VALVE SIZER SET | 1985-11-01 | 86 |
| K852612 | Medtronic Vascular | METRONIC MODEL F7700 HEART VALVE SIZERS | 1985-09-23 | 96 |
Recalls for DTI devices
2 product recalls in 1 recall events; 0 initiated in the last five years and 2 still open. Most recent: 2020-01-14.
| Year | Recalls |
|---|---|
| 2020 | 2 |
Frequently asked questions
What is FDA product code DTI?
DTI is the FDA product code for sizer, heart-valve, prosthesis. It is a Class I device, regulated under 21 CFR 870.3945 and reviewed by the Cardiovascular panel.
What device class is DTI?
Class I, regulation 21 CFR 870.3945. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code DTI?
Across 7 cleared submissions the average was 90 days from receipt to decision (median 86).
Which companies have the most DTI clearances?
Carbomedics, Inc. (2); Baxter Healthcare Corp (1); Hemex Scientific, Inc. (1); Medtronic Vascular (1); Celtech (1).
Have DTI devices been recalled?
Yes: 2 product recalls across 1 recall events; the most recent began 2020-01-14.
Next steps
- Run an FDA pathway report with predicate devices for product code DTI
- Run a recall and safety report across every DTI manufacturer
- Watch product code DTI 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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