DWP — Dilator, Vessel, Surgical Class II
FDA product code DWP covers "Dilator, Vessel, Surgical", a Class II medical device regulated under 21 CFR 870.4475. Submissions are reviewed by the Cardiovascular panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- DWP
- Device Class
- Class II
- Regulation Number
- 870.4475
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K220981 | fehling surgical instruments | SUPERPLAST Double-Occluder, SUPERPLAST Vascular Probe | April 20, 2023 |
| K183438 | geomed medizin-technik gmbh and | Geomed Vascular Dilators | September 3, 2019 |
| K163524 | fetzer medical gmbh and co. kg | Vessel Dilator | June 29, 2017 |
| K130896 | synovis life technologies | VASCULAR PROBE, VASCULAR PROBE ES | April 24, 2013 |
| K100518 | instrumed international | INSTRUMED VESSEL DILATORS, MODEL 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054 | August 31, 2010 |
| K030788 | geister medizin technik | KAMAR ANNULUS DILATOR + SIZER; GARRETT, COOLEY, AND DEBAKEY VESSEL DILATORS | July 12, 2003 |
| K960312 | r d intl | RDI CARDIAC INSULATION PAD | April 19, 1996 |
| K912548 | vascutech | LEMAITRE-BOOKWALTER VESSEL DEVICES | September 18, 1991 |
| K911475 | united states endoscopy group | LAPAROSCOPIC VESSEL ARTICULATOR | July 2, 1991 |
| K910682 | bio-vascular | ROBICSEK PROBE/RETRACTOR | May 8, 1991 |
| K905159 | bio-vascular | FLO-RESTER(R) VESSEL SIZER | February 7, 1991 |
| K902143 | baxter healthcare | FOGARTY VESSEL CALIBRATOR | October 16, 1990 |
| K891786 | pioneering technologies | PTI INTRA-ART(R) CORONARY ARTERY PROBE (STERILE) | October 12, 1989 |
| K833676 | cimed intl | SURGICAL VESSEL DILATORS-CATHERIZA- | March 19, 1984 |
| K832595 | abbott laboratories | VESSEL DILATOR | August 31, 1983 |
| K822687 | american edwards laboratories | REUSABLE FOGARTY FLEXIBLE CALIBRATOR | October 4, 1982 |
| K812935 | american edwards laboratories | FOGARTY FLEXIBLE PROBE | November 16, 1981 |
| K810894 | american edwards laboratories | FOGARTY FLEXIBLE CALIBRATOR | May 15, 1981 |
| K792134 | shiley | BONCHEK-SHILEY VEIN DISTENTION SYSTEM | December 4, 1979 |
| K790938 | shiley | SAPHENOUS VEIN IRRIGATION, PRESSURIZATIO | June 13, 1979 |