# K140306: Cormatrix Protect Ecm Envelope

- Pathway: 510(k) (Traditional)
- Applicant: Cormatrix Cardiovascular, Inc.
- Decided: Aug 15, 2014 after 189 days
- Product code: FTM (Mesh, Surgical)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K842066 (1985). 81 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 86 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063091: Pivit CRM (Tyrx Antimicrobial Pacemaker Pouch), Model CMRM-0601, Tyrx Pharma, Inc. (2008) Summary page 4.
- K130943: Aigis RX R PM/ Aigis RX R Icd, Tyrx, Inc. (2013) Summary page 4.
- K063349: Cormatrix Patch for Cardiac Tissue Repair, Cormatrix Cardiovascular, Inc. (2007) Summary page 4.
- K980431: Surgisis, Cook Biotech, Inc. (1998) Summary page 4.
- K062696: Surgisis, Surgisis ES, Cook Biotech, Inc. (2006) Summary page 4.
- K062697: Sis Hernia Repair Device, Surgisis Gold Hernia Repair Graft, Cook Biotech, Inc. (2006) Summary page 4.
- K073391: Surgisis Biodesign Tissue Graft, Cook Biotech, Inc. (2008) Summary page 4.

## Most influential descendants
- 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
- K192616: CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large), CanGaroo Envelope (extra extra large) (SubQ) (2019), 1 descendant of its own
- K201313: CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large), CanGaroo Enevlope (extra extra large) (SubQ) (2020), 0 descendants of its own

## Recalls of this device
- Aug 21, 2019 · Class II · Z-0039-2020: Possible suture brittleness or breakage along the Envelope seam before the expiration date of the device.
- Aug 21, 2019 · Class II · Z-0040-2020: Possible suture brittleness or breakage along the Envelope seam before the expiration date of the device.

## Indications for use
The CorMatrix PROTECT ECM Envelope is intended to securely hold an implantable electronic device to create a stable environment when implanted in the body. The devices that may be used with the CorMatrix PROTECT ECM Envelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices.

Source page: https://510kreport.com/device/K140306
Methodology: https://510kreport.com/methodology