510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K960532Substantially Equivalent

Preclude Ima Sleeve

W. L. Gore & Associates, Inc., Flagstaff AZ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K960532 is the FDA 510(k) clearance record for PRECLUDE IMA SLEEVE, a class II device, cleared for W. L. Gore & Associates, Inc. on under FDA product code MFX (Vessel Guard Or Cover, To Facilitate Revision Surgeries). FDA's definition for product code MFX reads: "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". FDA records list 169 510(k) clearances for W. L. Gore & Associates, Inc., from to . As of , FDA records show no recalls naming K960532.

Clearance record

Decision date
Received
(106 days to decision)
Product code
MFX Vessel Guard Or Cover, To Facilitate Revision Surgeries
Regulation
21 CFR 870.3470
Device class
Class II
Review panel
Cardiovascular
Applicant
W. L. Gore & Associates, Inc. 3450 W. Kiltie Ln., Flagstaff AZ
510(k) summary
Summary
Third party review
No

Clearances, product code MFX

Trailing 12 months

FDA records hold no clearances under product code MFX in the trailing twelve months.

FDA records show no clearances under product code MFX in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MFX, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260