The following data is part of a premarket notification filed by W.l. Gore & Associates,inc with the FDA for Preclude Ima Sleeve.
| Device ID | K960532 |
| 510k Number | K960532 |
| Device Name: | PRECLUDE IMA SLEEVE |
| Classification | Vessel Guard Or Cover, To Facilitate Revision Surgeries |
| Applicant | W.L. GORE & ASSOCIATES,INC 3450 WEST KILTIE LN. P.O. BOX 500 Flagstaff, AZ 86002 |
| Contact | R. Larry Pratt |
| Correspondent | R. Larry Pratt W.L. GORE & ASSOCIATES,INC 3450 WEST KILTIE LN. P.O. BOX 500 Flagstaff, AZ 86002 |
| Product Code | MFX |
| CFR Regulation Number | 870.3470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-02-07 |
| Decision Date | 1996-05-23 |
| Summary: | summary |