# K051405: Regensis Pericardial Patch

- Pathway: 510(k) (Traditional)
- Applicant: Cormatrix Cardiovascular, Inc.
- Decided: Aug 31, 2005 after 92 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: 4 generations back to K921895 (1992). 10 ancestors in all.
15 later devices descend from it; 5 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980431: Surgisis, Cook Biotech, Inc. (1998) Summary page 1.
- K020455: Tissuemend Soft Tissue Repair Matrix, Tei Biosciences, Inc. (2002) Summary page 1.
- K012098: Preclude Pericardial Membrane, W. L. Gore & Associates, Inc. (2001) Summary page 1.
- K031948: Peripatch Sheet, Models 1.5P8, 4P4, 4P6, 6P8, 10P16, 1.5P16, Pm Devices, Inc. (2003) Summary page 1.

## Most influential descendants
- K063349: Cormatrix Patch for Cardiac Tissue Repair (2007), 11 descendants of its own
- K140306: Cormatrix Protect Ecm Envelope (2014), 4 descendants of its own
- K173242: CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large) (2017), 3 descendants of its own
- K182255: CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo Neuro Envelope (large) ; CanGaroo Neuro Envelope (extra large) (2018), 2 descendants of its own
- K152127: CorMatrix Tyke (2016), 2 descendants of its own

## Indications for use
The CorMatrix Pericardial Patch is intended for the reconstruction and repair of the pericardium.

Source page: https://510kreport.com/device/K051405
Methodology: https://510kreport.com/methodology