510(k) Report

FDA applicant

Cormatrix Cardiovascular, Inc.

Roswell, GA7 decisions2005–20182 recalls

FDA records 7 decisions for Cormatrix Cardiovascular, Inc. (Roswell, GA) from 2005 to 2018: 7 510(k) clearances. Most are in product codes DXZ (Patch, Pledget And Intracardiac, Petp, Ptfe…) and FTM (Mesh, Surgical). Its devices cite 28 predicates, 7 of them its own earlier devices. 2 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Cormatrix Cardiovascular, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2007: 12011: 12014: 22016: 12018: 1
2007high 2 (2014) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

2in 2019

2019: 2
2007high 2 (2019) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Cormatrix Cardiovascular, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Cormatrix Cardiovascular, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • DXZPatch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene5decisions
  • FTMMesh, Surgical1decision
  • PSQIntracardiac Patch Or Pledget, Biologically Derived1decision

Whose devices does it build on?

Its devices cite 28 predicates; 7 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 14 times; 7 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K051405Regensis Pericardial PatchCormatrix Cardiovascular, Inc. · 20055cite it
  • K063349Cormatrix Patch for Cardiac Tissue RepairCormatrix Cardiovascular, Inc. · 20075cite it
  • K111187Patch, Pledget and IntracardiacCormatrix Cardiovascular, Inc. · 20111cites it
  • K152127CorMatrix TykeCormatrix Cardiovascular, Inc. · 20161cites it
  • K140306Cormatrix Protect Ecm EnvelopeCormatrix Cardiovascular, Inc. · 20141cites it
  • K181038CorMatrix Cor Patch (3 cm x 5 cm)(single pack), CorMatrix Cor Patch (4 cm x 7 cm)(single pack), CorMatrix…Cormatrix Cardiovascular, Inc. · 20181cites it

What has FDA decided for it lately?

  • K181038CorMatrix Cor Patch (3 cm x 5 cm)(single pack), CorMatrix Cor Patch (4 cm x 7 cm)(single pack), CorMatrix…Cormatrix Cardiovascular, Inc. · 2018
  • K152127CorMatrix TykeCormatrix Cardiovascular, Inc. · 2016
  • K140306Cormatrix Protect Ecm EnvelopeCormatrix Cardiovascular, Inc. · 20142 recalls
  • K140789Cormatrix Ecm for Vascular RepairCormatrix Cardiovascular, Inc. · 2014
  • K111187Patch, Pledget and IntracardiacCormatrix Cardiovascular, Inc. · 2011
  • K063349Cormatrix Patch for Cardiac Tissue RepairCormatrix Cardiovascular, Inc. · 2007
  • K051405Regensis Pericardial PatchCormatrix Cardiovascular, Inc. · 2005

All 7 as Cormatrix Cardiovascular, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K140306BioEnvelope, surgical mesh envelope. Labeled as the following: 1. BioEnvelope (Medium)…Aug 21, 2019Class II
  • K173242CanGaroo Envelopes labeled as the following: 1. CanGaroo Envelope (Large) (single pack)…Aug 21, 2019Class II