K061727 is an FDA 510(k) clearance for the GORE PRECLUDE VESSEL GUARD. This device is classified as a Vessel Guard Or Cover, To Facilitate Revision Surgeries (Class II - Special Controls, product code MFX).
Submitted by W.L. Gore & Associates, Inc. (Flagstaff, US). The FDA issued a Cleared decision on August 7, 2006, 49 days after receiving the submission on June 19, 2006.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3470. Wrap, Patch, Or Cover Intended To Protect Vessels From Injury During Surgery, With The Secondary Function Of Facilitating Revision Surgeries By Providing A Plane Of Dissection..
| 510(k) Number | K061727 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 19, 2006 |
| Decision Date | August 07, 2006 |
| Days to Decision | 49 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | MFX — Vessel Guard Or Cover, To Facilitate Revision Surgeries |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.3470 |
| Definition | Wrap, Patch, Or Cover Intended To Protect Vessels From Injury During Surgery, With The Secondary Function Of Facilitating Revision Surgeries By Providing A Plane Of Dissection. |