Product code DWP
- Device name
- Dilator, Vessel, Surgical
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.4475
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K220981 | SUPERPLAST Double-Occluder, SUPERPLAST Vascular Probe | Fehling Surgical Instruments, Inc. | 2023-04-20 |
| K183438 | Geomed Vascular Dilators | Geomed Medizin-Technik GmbH & Co. | 2019-09-03 |
| K163524 | Vessel Dilator | Fetzer Medical GmbH & Co. KG | 2017-06-29 |
| K130896 | VASCULAR PROBE, VASCULAR PROBE ES | Synovis Life Technologies, Inc. | 2013-04-24 |
| K100518 | INSTRUMED VESSEL DILATORS, MODEL 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054 | Instrumed International, Inc. | 2010-08-31 |
| K030788 | KAMAR ANNULUS DILATOR + SIZER; GARRETT, COOLEY, AND DEBAKEY VESSEL DILATORS | Geister Medizin Technik GmbH | 2003-07-12 |
| K960312 | RDI CARDIAC INSULATION PAD | R D Intl. | 1996-04-19 |
| K912548 | LEMAITRE-BOOKWALTER VESSEL DEVICES | Vascutech, Inc. | 1991-09-18 |
| K911475 | LAPAROSCOPIC VESSEL ARTICULATOR | United States Endoscopy Group, Inc. | 1991-07-02 |
| K910682 | ROBICSEK PROBE/RETRACTOR | Bio-Vascular, Inc. | 1991-05-08 |
| K905159 | FLO-RESTER(R) VESSEL SIZER | Bio-Vascular, Inc. | 1991-02-07 |
| K902143 | FOGARTY VESSEL CALIBRATOR | Baxter Healthcare Corp | 1990-10-16 |
| K891786 | PTI INTRA-ART(R) CORONARY ARTERY PROBE (STERILE) | Pioneering Technologies, Inc. | 1989-10-12 |
| K833676 | SURGICAL VESSEL DILATORS-CATHERIZA- | Cimed Intl., Inc. | 1984-03-19 |
| K832595 | VESSEL DILATOR | Abbott Laboratories | 1983-08-31 |
| K822687 | REUSABLE FOGARTY FLEXIBLE CALIBRATOR | American Edwards Laboratories | 1982-10-04 |
| K812935 | FOGARTY FLEXIBLE PROBE | American Edwards Laboratories | 1981-11-16 |
| K810894 | FOGARTY FLEXIBLE CALIBRATOR | American Edwards Laboratories | 1981-05-15 |
| K792134 | BONCHEK-SHILEY VEIN DISTENTION SYSTEM | Shiley, Inc. | 1979-12-04 |
| K790938 | SAPHENOUS VEIN IRRIGATION, PRESSURIZATIO | Shiley, Inc. | 1979-06-13 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10381780158059 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-17 |
| 10381780158042 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-17 |
| 10381780158035 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-17 |
| 10381780158028 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-17 |
| 10381780158011 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-17 |
| 10381780158004 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-17 |
| 10381780157991 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-17 |
| 10381780157984 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-17 |
| 10381780157977 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-17 |
| 10381780157960 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-17 |
| 10381780157915 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-14 |
| 10381780157953 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-14 |
| 10381780157946 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-14 |
| 10381780157939 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-14 |
| 10381780157922 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-14 |
| 10381780157762 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-14 |
| 10381780157908 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-14 |
| 10381780157892 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-14 |
| 10381780157885 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-14 |
| 10381780157878 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-14 |
| 10381780157861 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-14 |
| 10381780157854 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-14 |
| 10381780157847 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-14 |
| 10381780157830 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-14 |
| 10381780157823 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-14 |
| 10381780157816 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-14 |
| 10381780157809 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-14 |
| 10381780157793 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-14 |
| 10381780157786 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-14 |
| 10381780157779 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-14 |