# K190882: XenoSure Biologic Patch

- Pathway: 510(k) (Traditional)
- Applicant: Lemaitre Vascular
- Decided: Feb 13, 2020 after 315 days
- Product code: PSQ (Intracardiac Patch Or Pledget, Biologically Derived)
- 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: 4 generations back to K842066 (1985). 11 ancestors in all.
No later device cites it as a predicate yet.
1 of 12 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040835: Peripatch Sheet, Models 1.5P8, 1.5P16, 4P4, 4P6, 6P8 and 10P16, Pm Devices, Inc. (2004) Summary page 4.

## Indications for use
The XenoSure Biologic Patch is intended for use as a surgical patch material for cardiac and vascular reconstruction and repair, soft tissue deficiency repair and reinforcing the suture line during general surgical procedures.

Source page: https://510kreport.com/device/K190882
Methodology: https://510kreport.com/methodology