# K811841: Gore-Tex Cardiovascular Patch

- Pathway: 510(k) (Traditional)
- Applicant: W. L. Gore & Associates, Inc.
- Decided: Sep 16, 1981 after 77 days
- Product code: DXZ (Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene)
- 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.
12 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K984526: Acuseal Cardiovascular Patch (1999), 9 descendants of its own
- K061727: Gore Preclude Vessel Guard (2006), 6 descendants of its own
- K082782: Replication Medical Vessel Guard (2009), 3 descendants of its own
- K962342: Hemashield Finesse Ultra-Thin, Knitted Cardiovascular Patch (1996), 3 descendants of its own
- K112683: Smi Cardiovascular Pach (2011), 1 descendant of its own

Source page: https://510kreport.com/device/K811841
Methodology: https://510kreport.com/methodology