FDA product code DWP: Dilator, Vessel, Surgical
DWP is the FDA product code for dilator, vessel, surgical. It is a Class II device, regulated under 21 CFR 870.4475 and reviewed by the Cardiovascular panel. FDA has cleared 20 510(k) submissions under DWP, 1 in the last five years, from 16 different applicants. The average 510(k) review took 116 days (median 88). FDA has posted 1 recall for DWP devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Dilator, Vessel, Surgical |
| Device class | Class II |
| Regulation | 21 CFR 870.4475 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for DWP
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 196 |
| 2019 | 1 | 265 |
| 2023 | 1 | 381 |
Compare with all 510(k) review times · Search every DWP clearance
Top DWP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| American Edwards Laboratories | 3 | 1982-10-04 |
| Bio-Vascular, Inc. | 2 | 1991-05-08 |
| Shiley, Inc. | 2 | 1979-12-04 |
| Fehling Surgical Instruments, Inc. | 1 | 2023-04-20 |
| Geomed Medizin-Technik GmbH & Co. | 1 | 2019-09-03 |
11 more applicants have DWP clearances. See the full list in Caduvo.
Most recent DWP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K220981 | Fehling Surgical Instruments, Inc. | SUPERPLAST Double-Occluder, SUPERPLAST Vascular Probe | 2023-04-20 | 381 |
| K183438 | Geomed Medizin-Technik GmbH & Co. | Geomed Vascular Dilators | 2019-09-03 | 265 |
| K163524 | Fetzer Medical GmbH & Co. KG | Vessel Dilator | 2017-06-29 | 196 |
| K130896 | Synovis Life Technologies, Inc. | VASCULAR PROBE, VASCULAR PROBE ES | 2013-04-24 | 23 |
| K100518 | Instrumed International, Inc. | INSTRUMED VESSEL DILATORS, MODEL 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054 | 2010-08-31 | 189 |
Recalls for DWP devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2023-12-06.
| Year | Recalls |
|---|---|
| 2023 | 1 |
Frequently asked questions
What is FDA product code DWP?
DWP is the FDA product code for dilator, vessel, surgical. It is a Class II device, regulated under 21 CFR 870.4475 and reviewed by the Cardiovascular panel.
What device class is DWP?
Class II, regulation 21 CFR 870.4475. Typical premarket route: 510(k).
How long does a 510(k) take for product code DWP?
Across 20 cleared submissions the average was 116 days from receipt to decision (median 88).
Which companies have the most DWP clearances?
American Edwards Laboratories (3); Bio-Vascular, Inc. (2); Shiley, Inc. (2); Fehling Surgical Instruments, Inc. (1); Geomed Medizin-Technik GmbH & Co. (1).
Have DWP devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2023-12-06.
Next steps
- Run an FDA pathway report with predicate devices for product code DWP
- Run a recall and safety report across every DWP manufacturer
- Watch product code DWP 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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