FDA Product Code
FDA Product Code DWP — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.4475
510(k) Clearances — 20 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K220981 | SUPERPLAST Double-Occluder, SUPERPLAST Vascular Probe | Fehling Surgical Instruments, Inc. | 2023-04-20 | Traditional | PDF ↗ |
| K183438 | Geomed Vascular Dilators | Geomed Medizin-Technik GmbH & Co. | 2019-09-03 | Traditional | PDF ↗ |
| K163524 | Vessel Dilator | Fetzer Medical GmbH & Co. KG | 2017-06-29 | Traditional | PDF ↗ |
| K130896 | VASCULAR PROBE, VASCULAR PROBE ES | Synovis Life Technologies, Inc. | 2013-04-24 | Traditional | PDF ↗ |
| K100518 | INSTRUMED VESSEL DILATORS, MODEL 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054 | Instrumed International, Inc. | 2010-08-31 | Traditional | PDF ↗ |
| K030788 | KAMAR ANNULUS DILATOR + SIZER; GARRETT, COOLEY, AND DEBAKEY VESSEL DILATORS | Geister Medizin Technik GmbH | 2003-07-12 | Traditional | PDF ↗ |
| K960312 | RDI CARDIAC INSULATION PAD | R D Intl. | 1996-04-19 | Traditional | PDF ↗ |
| K912548 | LEMAITRE-BOOKWALTER VESSEL DEVICES | Vascutech, Inc. | 1991-09-18 | Traditional | PDF ↗ |
| K911475 | LAPAROSCOPIC VESSEL ARTICULATOR | United States Endoscopy Group, Inc. | 1991-07-02 | Traditional | PDF ↗ |
| K910682 | ROBICSEK PROBE/RETRACTOR | Bio-Vascular, Inc. | 1991-05-08 | Traditional | PDF ↗ |
| K905159 | FLO-RESTER(R) VESSEL SIZER | Bio-Vascular, Inc. | 1991-02-07 | Traditional | PDF ↗ |
| K902143 | FOGARTY VESSEL CALIBRATOR | Baxter Healthcare Corp | 1990-10-16 | Traditional | PDF ↗ |
| K891786 | PTI INTRA-ART(R) CORONARY ARTERY PROBE (STERILE) | Pioneering Technologies, Inc. | 1989-10-12 | Traditional | PDF ↗ |
| K833676 | SURGICAL VESSEL DILATORS-CATHERIZA- | Cimed Intl., Inc. | 1984-03-19 | Traditional | PDF ↗ |
| K832595 | VESSEL DILATOR | Abbott Laboratories | 1983-08-31 | Traditional | PDF ↗ |
| K822687 | REUSABLE FOGARTY FLEXIBLE CALIBRATOR | American Edwards Laboratories | 1982-10-04 | Traditional | PDF ↗ |
| K812935 | FOGARTY FLEXIBLE PROBE | American Edwards Laboratories | 1981-11-16 | Traditional | PDF ↗ |
| K810894 | FOGARTY FLEXIBLE CALIBRATOR | American Edwards Laboratories | 1981-05-15 | Traditional | PDF ↗ |
| K792134 | BONCHEK-SHILEY VEIN DISTENTION SYSTEM | Shiley, Inc. | 1979-12-04 | Traditional | PDF ↗ |
| K790938 | SAPHENOUS VEIN IRRIGATION, PRESSURIZATIO | Shiley, Inc. | 1979-06-13 | Traditional | PDF ↗ |
Product code DWP · Class II · Cardiovascular. Data: openFDA.