DWX — Stripper, Artery, Intraluminal Class II
FDA product code DWX covers "Stripper, Artery, Intraluminal", a Class II medical device regulated under 21 CFR 870.4875. Submissions are reviewed by the Cardiovascular panel. At least 14 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- DWX
- Device Class
- Class II
- Regulation Number
- 870.4875
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K121415 | lemaitre vascular | MOLLRING MULTITASC | September 5, 2012 |
| K032105 | endarx | ENDOHELIX ENDARTERECTOMY DEVICE | October 30, 2003 |
| K020925 | endo surgical devices | CARBODISSECTING ENDOSCOPE | April 29, 2003 |
| K003719 | vascular architects | VASCULAR ARCHITECTS PERISCOPE DEVICE | February 28, 2001 |
| K950813 | cardio vascular concepts | MOLLRING CUTTER | July 25, 1995 |
| K933498 | applied medical resources | EXTERNAL VEIN STRIPPER | March 23, 1994 |
| K913803 | omni-tract surgical, div. minn. scientific | INTRALUMINAL ARTERY STRIPPER | April 24, 1992 |
| K911099 | pilling | MEHIGAN-PILLING ANGIOSCOPIC VASCULAR INSTRUM. LINE | June 25, 1991 |
| K904944 | baxter healthcare | TRANSLUMINAL ENDARTERECTOMY DEVICE | December 17, 1990 |
| K895878 | olympus | OLYMPUS VALVULOTOME W/DETACHABLE TIP | January 2, 1990 |
| K894496 | olympus | OLYMPUS VALVULOTOME W/FIXED TIP | October 12, 1989 |
| K890515 | intensive technology | PERIPHERAL ATHERECTOMY SYSTEM | May 23, 1989 |
| K841521 | scanlan intl | SCANLAN ENDARSECTOR | August 3, 1984 |
| K801063 | american sterilizer | HALL ARTERIAL OSCILLATOR | September 26, 1980 |