The following data is part of a premarket notification filed by W.l. Gore & Associates,inc with the FDA for Gore Preclude Vessel Guard.
| Device ID | K061727 |
| 510k Number | K061727 |
| Device Name: | GORE PRECLUDE VESSEL GUARD |
| Classification | Vessel Guard Or Cover, To Facilitate Revision Surgeries |
| Applicant | W.L. GORE & ASSOCIATES,INC 1505 NORTH FOURTH ST. Flagstaff, AZ 86003 -3000 |
| Contact | Michael Ivey |
| Correspondent | Michael Ivey W.L. GORE & ASSOCIATES,INC 1505 NORTH FOURTH ST. Flagstaff, AZ 86003 -3000 |
| Product Code | MFX |
| CFR Regulation Number | 870.3470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-19 |
| Decision Date | 2006-08-07 |
| Summary: | summary |