K960532 is an FDA 510(k) clearance for the PRECLUDE IMA SLEEVE. 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 May 23, 1996, 106 days after receiving the submission on February 7, 1996.
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 | K960532 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 07, 1996 |
| Decision Date | May 23, 1996 |
| Days to Decision | 106 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. |