# K090637: Cardio-Wrap

- Pathway: 510(k) (Traditional)
- Applicant: Mast Biosurgery USA, Inc.
- Decided: Jan 7, 2010 after 303 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: 5 generations back to K921895 (1992). 25 ancestors in all.
No later device cites it as a predicate yet.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031785: Macropore Cardio-Wrap (TS), Macropore Biosurgery, Inc. (2003) Summary page 3.
- K051405: Regensis Pericardial Patch, Cormatrix Cardiovascular, Inc. (2005) Summary page 3.
- K983602: CV Peri-Guard and Vascu-Guard, Bio-Vascular, Inc. (1998) Summary page 3.
- K960532: Preclude Ima Sleeve, W. L. Gore & Associates, Inc. (1996) Summary page 3.
- K061727: Gore Preclude Vessel Guard, W. L. Gore & Associates, Inc. (2006) Summary page 3.
- K031955: Macropore Surgi-Wrap Mast Bioresorbable Sheet, Macropore Biosurgery, Inc. (2003) Summary page 3.

## Indications for use
The Cardio-Wrap Bioresorbable Sheet is intended for reconstruction and repair of defects of the pericardium

Source page: https://510kreport.com/device/K090637
Methodology: https://510kreport.com/methodology