DWP · Dilator, Vessel, Surgical
Cardiovascular · 21 CFR 870.4475 · Class 2
Overview
| Product Code | DWP |
|---|---|
| Device Name | Dilator, Vessel, Surgical |
| Regulation | 21 CFR 870.4475 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| 3rd-Party Reviewable | Yes |
Identification
A surgical vessel dilator is a device used to enlarge or calibrate a vessel.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 20)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K220981 | SUPERPLAST Double-Occluder, SUPERPLAST Vascular Probe | Fehling Surgical Instruments, Inc. | Apr 20, 2023 | SESE |
| K183438 | Geomed Vascular Dilators | Geomed Medizin-Technik GmbH & Co. | Sep 3, 2019 | SESE |
| K163524 | Vessel Dilator | Fetzer Medical GmbH & Co. KG | Jun 29, 2017 | SESE |
| K130896 | VASCULAR PROBE, VASCULAR PROBE ES | Synovis Life Technologies, Inc. | Apr 24, 2013 | SESE |
| K100518 | INSTRUMED VESSEL DILATORS, MODEL 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054 | Instrumed International, Inc. | Aug 31, 2010 | SESE |
| K030788 | KAMAR ANNULUS DILATOR + SIZER; GARRETT, COOLEY, AND DEBAKEY VESSEL DILATORS | Geister Medizin Technik GmbH | Jul 12, 2003 | SESE |
| K960312 | RDI CARDIAC INSULATION PAD | R D Intl. | Apr 19, 1996 | SESE |
| K912548 | LEMAITRE-BOOKWALTER VESSEL DEVICES | Vascutech, Inc. | Sep 18, 1991 | SESE |
| K911475 | LAPAROSCOPIC VESSEL ARTICULATOR | United States Endoscopy Group, Inc. | Jul 2, 1991 | SESE |
| K910682 | ROBICSEK PROBE/RETRACTOR | Bio-Vascular, Inc. | May 8, 1991 | SESE |
| K905159 | FLO-RESTER(R) VESSEL SIZER | Bio-Vascular, Inc. | Feb 7, 1991 | SESE |
| K902143 | FOGARTY VESSEL CALIBRATOR | Baxter Healthcare Corp | Oct 16, 1990 | SESE |
| K891786 | PTI INTRA-ART(R) CORONARY ARTERY PROBE (STERILE) | Pioneering Technologies, Inc. | Oct 12, 1989 | SESE |
| K833676 | SURGICAL VESSEL DILATORS-CATHERIZA- | Cimed Intl., Inc. | Mar 19, 1984 | SESE |
| K832595 | VESSEL DILATOR | Abbott Laboratories | Aug 31, 1983 | SESE |
| K822687 | REUSABLE FOGARTY FLEXIBLE CALIBRATOR | American Edwards Laboratories | Oct 4, 1982 | SESE |
| K812935 | FOGARTY FLEXIBLE PROBE | American Edwards Laboratories | Nov 16, 1981 | SESE |
| K810894 | FOGARTY FLEXIBLE CALIBRATOR | American Edwards Laboratories | May 15, 1981 | SESE |
| K792134 | BONCHEK-SHILEY VEIN DISTENTION SYSTEM | Shiley, Inc. | Dec 4, 1979 | SESE |
| K790938 | SAPHENOUS VEIN IRRIGATION, PRESSURIZATIO | Shiley, Inc. | Jun 13, 1979 | SESE |
Top Applicants
- American Edwards Laboratories — 3 clearances
- Shiley, Inc. — 2 clearances
- Bio-Vascular, Inc. — 2 clearances
- Vascutech, Inc. — 1 clearance
- United States Endoscopy Group, Inc. — 1 clearance
