# K101740: Albosure Polyester Vascular Patch

- Pathway: 510(k) (Traditional)
- Applicant: LeMaitre Vascular, Inc.
- Decided: Sep 20, 2010 after 91 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: 2 generations back to K811841 (1981). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962342: Hemashield Finesse Ultra-Thin, Knitted Cardiovascular Patch, Meadox Medicals, Div. Boston Scientific Corp. (1996) Summary page 1.

## Indications for use
The AlboSure Polyester Vascular Patch is indicated for cardiac and vascular patch grafting. The fabric is recommended for use in patients requiring systemic heparinization prior to, or during, surgery.

Source page: https://510kreport.com/device/K101740
Methodology: https://510kreport.com/methodology