FDA product code DST: Clip, Vena-Cava
DST is the FDA product code for clip, vena-cava. It is a Class II device, regulated under 21 CFR 870.3260 and reviewed by the Cardiovascular panel. FDA has cleared 1 510(k) submission under DST. The average 510(k) review took 196 days (median 196).
Classification
| Field | Value |
|---|---|
| Device name | Clip, Vena-Cava |
| Device class | Class II |
| Regulation | 21 CFR 870.3260 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Implant | Yes |
Compare with all 510(k) review times · Search every DST clearance
Top DST applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medicomp, Inc. | 1 | 1990-07-31 |
Most recent DST clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K900207 | Medicomp, Inc. | EPICARDIA 4000 | 1990-07-31 | 196 |
Recalls for DST devices
openFDA lists no recalls for product code DST.
Frequently asked questions
What is FDA product code DST?
DST is the FDA product code for clip, vena-cava. It is a Class II device, regulated under 21 CFR 870.3260 and reviewed by the Cardiovascular panel.
What device class is DST?
Class II, regulation 21 CFR 870.3260. Typical premarket route: 510(k).
How long does a 510(k) take for product code DST?
Across 1 cleared submissions the average was 196 days from receipt to decision (median 196).
Which companies have the most DST clearances?
Medicomp, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DST
- Run a recall and safety report across every DST manufacturer
- Watch product code DST 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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