FDA product code DWX: Stripper, Artery, Intraluminal
DWX is the FDA product code for stripper, artery, intraluminal. It is a Class II device, regulated under 21 CFR 870.4875 and reviewed by the Cardiovascular panel. FDA has cleared 14 510(k) submissions under DWX, from 13 different applicants. The average 510(k) review took 147 days (median 114).
Classification
| Field | Value |
|---|---|
| Device name | Stripper, Artery, Intraluminal |
| Device class | Class II |
| Regulation | 21 CFR 870.4875 |
| 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 DWX clearance
Top DWX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Olympus Corp. | 2 | 1990-01-02 |
| LeMaitre Vascular, Inc. | 1 | 2012-09-05 |
| Endarx, Inc. | 1 | 2003-10-30 |
| Endo Surgical Devices, Inc. | 1 | 2003-04-29 |
| Vascular Architects, Inc. | 1 | 2001-02-28 |
8 more applicants have DWX clearances. See the full list in Caduvo.
Most recent DWX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K121415 | LeMaitre Vascular, Inc. | MOLLRING MULTITASC | 2012-09-05 | 117 |
| K032105 | Endarx, Inc. | ENDOHELIX ENDARTERECTOMY DEVICE | 2003-10-30 | 114 |
| K020925 | Endo Surgical Devices, Inc. | CARBODISSECTING ENDOSCOPE | 2003-04-29 | 404 |
| K003719 | Vascular Architects, Inc. | VASCULAR ARCHITECTS PERISCOPE DEVICE | 2001-02-28 | 86 |
| K950813 | Cardio Vascular Concepts, Inc. | MOLLRING CUTTER | 1995-07-25 | 153 |
Recalls for DWX devices
openFDA lists no recalls for product code DWX.
Frequently asked questions
What is FDA product code DWX?
DWX is the FDA product code for stripper, artery, intraluminal. It is a Class II device, regulated under 21 CFR 870.4875 and reviewed by the Cardiovascular panel.
What device class is DWX?
Class II, regulation 21 CFR 870.4875. Typical premarket route: 510(k).
How long does a 510(k) take for product code DWX?
Across 14 cleared submissions the average was 147 days from receipt to decision (median 114).
Which companies have the most DWX clearances?
Olympus Corp. (2); LeMaitre Vascular, Inc. (1); Endarx, Inc. (1); Endo Surgical Devices, Inc. (1); Vascular Architects, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DWX
- Run a recall and safety report across every DWX manufacturer
- Watch product code DWX 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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