Panels › Cardiovascular › Product code DWP · Class 2
Dilator, Vessel, Surgical
Regulation 870.4475
0510(k)s in 12 months (20 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in DWP
| Company | 510(k)s | Recalls |
|---|---|---|
| American Edwards Laboratories | 3 | 0 |
| Baxter Healthcare Corp | 1 | 1 |
| Bio-Vascular, Inc. | 2 | 0 |
| Shiley, Inc. | 2 | 0 |
| Abbott Laboratories | 1 | 0 |
| Cimed Intl., Inc. | 1 | 0 |
| Fehling Surgical Instruments, Inc. | 1 | 0 |
| Fetzer Medical GmbH & Co. KG | 1 | 0 |
| Geister Medizin Technik GmbH | 1 | 0 |
| Geomed Medizin-Technik GmbH & Co. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 20, 2023 | K220981 | SUPERPLAST Double-Occluder, SUPERPLAST Vascular Probe Fehling Surgical Instruments, Inc. | DWP |
| Sep 3, 2019 | K183438 | Geomed Vascular Dilators Geomed Medizin-Technik GmbH & Co., DE | DWP |
| Jun 29, 2017 | K163524 | Vessel Dilator Fetzer Medical GmbH & Co. KG, DE | DWP |
| Apr 24, 2013 | K130896 | VASCULAR PROBE, VASCULAR PROBE ES Synovis Life Technologies, Inc. | DWP |
| Aug 31, 2010 | K100518 | INSTRUMED VESSEL DILATORS, MODEL 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054 Instrumed International, Inc. | DWP |
| Jul 12, 2003 | K030788 | KAMAR ANNULUS DILATOR + SIZER; GARRETT, COOLEY, AND DEBAKEY VESSEL DILATORS Geister Medizin Technik GmbH, NL | DWP |
| Apr 19, 1996 | K960312 | RDI CARDIAC INSULATION PAD R D Intl. | DWP |
| Sep 18, 1991 | K912548 | LEMAITRE-BOOKWALTER VESSEL DEVICES Vascutech, Inc. | DWP |
| Jul 2, 1991 | K911475 | LAPAROSCOPIC VESSEL ARTICULATOR United States Endoscopy Group, Inc. | DWP |
| May 8, 1991 | K910682 | ROBICSEK PROBE/RETRACTOR Bio-Vascular, Inc. | DWP |
| Feb 7, 1991 | K905159 | FLO-RESTER(R) VESSEL SIZER Bio-Vascular, Inc. | DWP |
| Oct 16, 1990 | K902143 | FOGARTY VESSEL CALIBRATOR Baxter Healthcare Corp | DWP |
| Oct 12, 1989 | K891786 | PTI INTRA-ART(R) CORONARY ARTERY PROBE (STERILE) Pioneering Technologies, Inc. | DWP |
| Mar 19, 1984 | K833676 | SURGICAL VESSEL DILATORS-CATHERIZA- Cimed Intl., Inc. | DWP |
| Aug 31, 1983 | K832595 | VESSEL DILATOR Abbott Laboratories | DWP |
| Oct 4, 1982 | K822687 | REUSABLE FOGARTY FLEXIBLE CALIBRATOR American Edwards Laboratories | DWP |
| Nov 16, 1981 | K812935 | FOGARTY FLEXIBLE PROBE American Edwards Laboratories | DWP |
| May 15, 1981 | K810894 | FOGARTY FLEXIBLE CALIBRATOR American Edwards Laboratories | DWP |
| Dec 4, 1979 | K792134 | BONCHEK-SHILEY VEIN DISTENTION SYSTEM Shiley, Inc. | DWP |
| Jun 13, 1979 | K790938 | SAPHENOUS VEIN IRRIGATION, PRESSURIZATIO Shiley, Inc. | DWP |
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