# K031785: Macropore Cardio-Wrap (TS)

- Pathway: 510(k) (Traditional)
- Applicant: Macropore Biosurgery, Inc.
- Decided: Sep 4, 2003 after 86 days
- Product code: OMH (Pericardial Patch To Facilitate Revision Surgeries)
- 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: 3 generations back to K921895 (1992). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983602: CV Peri-Guard and Vascu-Guard, Bio-Vascular, Inc. (1998) Summary page 3.
- K993288: Sulzer Carbomedics Cardiofix Pericardium, Sulzer Carbomedics, Inc. (1999) Summary page 3.
- K012098: Preclude Pericardial Membrane, W. L. Gore & Associates, Inc. (2001)

## Most influential descendants
- K090637: Cardio-Wrap (2010), 0 descendants of its own

## Indications for use
The MacroPore Cardio-Wrap (TS) is indicated for use as a pericardium replacement device in patients that may require re-operation within six months.

Source page: https://510kreport.com/device/K031785
Methodology: https://510kreport.com/methodology