# K984526: Acuseal Cardiovascular Patch

- Pathway: 510(k) (Traditional)
- Applicant: W. L. Gore & Associates, Inc.
- Decided: Apr 8, 1999 after 108 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
Longest line of descent: 1 generation back to K811841 (1981). 3 ancestors in all.
9 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)
- K811841: Gore-Tex Cardiovascular Patch, W. L. Gore & Associates, Inc. (1981) Summary page 1.
- K912107: Gore-Tex Expanded Poly. Card. Patch 0.6 and 0.4MM, W. L. Gore & Associates, Inc. (1991) Summary page 1.
- K943736: Cvpro Cardiovascular Patch, W. L. Gore & Associates, Inc. (1995) Summary page 1.

## Most influential descendants
- K061727: Gore Preclude Vessel Guard (2006), 6 descendants of its own
- K082782: Replication Medical Vessel Guard (2009), 3 descendants of its own
- K112683: Smi Cardiovascular Pach (2011), 1 descendant of its own
- K103558: Synthes Scout Vessel Guard (2011), 1 descendant of its own
- K122105: Smi Cardiovascular Patch (2012), 0 descendants of its own

## Indications for use
The ACUSEAL™ Cardiovascular Patch is indicated for use in cardiovascular patching.

Source page: https://510kreport.com/device/K984526
Methodology: https://510kreport.com/methodology