# K960532: Preclude Ima Sleeve

- Pathway: 510(k) (Traditional)
- Applicant: W. L. Gore & Associates, Inc.
- Decided: May 23, 1996 after 106 days
- Product code: MFX (Vessel Guard Or Cover, To Facilitate Revision Surgeries)
- Device class: 2
- Regulation: 21 CFR 870.3470
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 3 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) PRECLUDE™ Pericardial Membrane: named in the summary without a submission number

## Most influential descendants
- K082782: Replication Medical Vessel Guard (2009), 3 descendants of its own
- K103558: Synthes Scout Vessel Guard (2011), 1 descendant of its own
- K111048: Synthes Scout Tack Fixation (2012), 0 descendants of its own
- K100984: Xylos Vessel Guard (2010), 0 descendants of its own
- K090637: Cardio-Wrap (2010), 0 descendants of its own

## Indications for use
For use as a wrap for pedicled arterial conduits. The device identifies and protects pedicled arterial conduits during reoperative cardiac surgery.

Source page: https://510kreport.com/device/K960532
Methodology: https://510kreport.com/methodology