# K962342: Hemashield Finesse Ultra-Thin, Knitted Cardiovascular Patch

- Pathway: 510(k) (Traditional)
- Applicant: Meadox Medicals, Div. Boston Scientific Corp.
- Decided: Sep 10, 1996 after 84 days
- Product code: DXZ (Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene)
- Device class: 2
- Regulation: 21 CFR 870.3470
- Recalls of this device: 2 (0 Class I)
- 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.
3 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955349: Hemashield Knitted Double Velour Cardiovascular Fabric, Meadox Medicals, Div. Boston Scientific Corp. (1996) Summary page 1.
- K821717: Gore-Tes Expanded Ptfe Patch, W. L. Gore & Associates, Inc. (1983) Summary page 1.
- K811841: Gore-Tex Cardiovascular Patch, W. L. Gore & Associates, Inc. (1981) Summary page 1.

## Most influential descendants
- K112683: Smi Cardiovascular Pach (2011), 1 descendant of its own
- K122105: Smi Cardiovascular Patch (2012), 0 descendants of its own
- K101740: Albosure Polyester Vascular Patch (2010), 0 descendants of its own

## Recalls of this device
- Dec 7, 2010 · Not classified · Z-1593-2011: One unit of Hemashield Finesse Ultra-thin Knitted Cardiovascular Patch which did not meet the internal release criteria for water permeability was distributed.
- May 24, 2010 · Not classified · Z-2064-2010: Various Hemashield products may develop glycerol droplets on the inner blister of the package if not stored under proper conditions, which could lead to the prolongation of surgery and potentially com

## Indications for use
The HEMASHIELD FINESSE™ Ultra-Thin, Knitted Cardiovascular Patch is indicated for cardiac and vascular patch grafting. The fabric is also recommended for use in patients requiring systemic heparinization prior to, or during, surgery.

Source page: https://510kreport.com/device/K962342
Methodology: https://510kreport.com/methodology