Dilator, Vessel, Surgical
FDA product code DWP · Class II (moderate risk) · 21 CFR 870.4475 · Cardiovascular
20510(k) clearances
0PMA approvals
1recalls
Manufacturers
- American Edwards Laboratories 3
- Shiley, Inc. 2
- Bio-Vascular, Inc. 2
- Abbott Laboratories 1
- Cimed Intl., Inc. 1
- Pioneering Technologies, Inc. 1
- Baxter Healthcare Corp 1
- United States Endoscopy Group, Inc. 1
- Vascutech, Inc. 1
- R D Intl. 1
- Geister Medizin Technik GmbH 1
- Instrumed International, Inc. 1
- Synovis Life Technologies, Inc. 1
- Fetzer Medical GmbH & Co. KG 1
- Geomed Medizin-Technik GmbH & Co. 1
- Fehling Surgical Instruments, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K220981 | SUPERPLAST Double-Occluder, SUPERPLAST Vascular ProbeDWP · Traditional | Fehling Surgical Instruments, Inc. | 04/20/2023SE |
| K183438 | Geomed Vascular DilatorsDWP · Traditional | Geomed Medizin-Technik GmbH & Co. | 09/03/2019SE |
| K163524 | Vessel DilatorDWP · Traditional | Fetzer Medical GmbH & Co. KG | 06/29/2017SE |
| K130896 | Vascular Probe, Vascular Probe EsDWP · Traditional | Synovis Life Technologies, Inc. | 04/24/2013SE |
| K100518 | Instrumed Vessel Dilators, Model 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054DWP · Traditional | Instrumed International, Inc. | 08/31/2010SE |
| K030788 | Kamar Annulus Dilator + Sizer; Garrett, Cooley, and Debakey Vessel DilatorsDWP · Traditional | Geister Medizin Technik GmbH | 07/12/2003SE |
| K960312 | Rdi Cardiac Insulation PadDWP · Traditional | R D Intl. | 04/19/1996SE |
| K912548 | Lemaitre-Bookwalter Vessel DevicesDWP · Traditional | Vascutech, Inc. | 09/18/1991SE |
| K911475 | Laparoscopic Vessel ArticulatorDWP · Traditional | United States Endoscopy Group, Inc. | 07/02/1991SE |
| K910682 | Robicsek Probe/RetractorDWP · Traditional | Bio-Vascular, Inc. | 05/08/1991SE |
| K905159 | Flo-Rester(R) Vessel SizerDWP · Traditional | Bio-Vascular, Inc. | 02/07/1991SE |
| K902143 | Fogarty Vessel CalibratorDWP · Traditional | Baxter Healthcare Corp | 10/16/1990SE |
| K891786 | Pti Intra-Art(R) Coronary Artery Probe (Sterile)DWP · Traditional | Pioneering Technologies, Inc. | 10/12/1989SE |
| K833676 | Surgical Vessel Dilators-Catheriza-DWP · Traditional | Cimed Intl., Inc. | 03/19/1984SE |
| K832595 | Vessel DilatorDWP · Traditional | Abbott Laboratories | 08/31/1983SE |
| K822687 | Reusable Fogarty Flexible CalibratorDWP · Traditional | American Edwards Laboratories | 10/04/1982SE |
| K812935 | Fogarty Flexible ProbeDWP · Traditional | American Edwards Laboratories | 11/16/1981SE |
| K810894 | Fogarty Flexible CalibratorDWP · Traditional | American Edwards Laboratories | 05/15/1981SE |
| K792134 | Bonchek-Shiley Vein Distention SystemDWP · Traditional | Shiley, Inc. | 12/04/1979SE |
| K790938 | Saphenous Vein Irrigation, PressurizatioDWP · Traditional | Shiley, Inc. | 06/13/1979SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0659-2024 Class II | Baxter Vascular Probe, Product Codes: a) 7081015: 8CM, 1- 1.5 MM GLOBAL, b) 7081520:…Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed… | Baxter Healthcare Corporation | 12/06/2023Open, Classified |