FDA product code DXP: Transducer, Vessel Occlusion
DXP is the FDA product code for transducer, vessel occlusion. It is a Class II device, regulated under 21 CFR 870.2890 and reviewed by the Cardiovascular panel. FDA has cleared 2 510(k) submissions under DXP, from 2 different applicants. The average 510(k) review took 58 days (median 58).
Classification
| Field | Value |
|---|---|
| Device name | Transducer, Vessel Occlusion |
| Device class | Class II |
| Regulation | 21 CFR 870.2890 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every DXP clearance
Top DXP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ingress Technologies, Inc. | 1 | 1989-06-15 |
| Frontier Products | 1 | 1981-10-02 |
Most recent DXP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K891180 | Ingress Technologies, Inc. | TRANSESOPHAGEAL ULTRASOUND ACCESSORIES KIT | 1989-06-15 | 101 |
| K812639 | Frontier Products | UNICUFF | 1981-10-02 | 16 |
Recalls for DXP devices
openFDA lists no recalls for product code DXP.
Frequently asked questions
What is FDA product code DXP?
DXP is the FDA product code for transducer, vessel occlusion. It is a Class II device, regulated under 21 CFR 870.2890 and reviewed by the Cardiovascular panel.
What device class is DXP?
Class II, regulation 21 CFR 870.2890. Typical premarket route: 510(k).
How long does a 510(k) take for product code DXP?
Across 2 cleared submissions the average was 58 days from receipt to decision (median 58).
Which companies have the most DXP clearances?
Ingress Technologies, Inc. (1); Frontier Products (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DXP
- Run a recall and safety report across every DXP manufacturer
- Watch product code DXP 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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