510(k) · Cleared
ClearedCormatrix Patch for Cardiac Tissue Repair
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cormatrix Cardiovascular, Inc. · DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Cleared on Feb 16, 2007 as substantially equivalent to K980431 (Cook Biotech, Inc., 1998) and 6 other predicates after a 102-day review. Its family tree reaches back 5 generations to 1992. 11 later devices descend from it.
- Decided
- Feb 16, 2007
- Review
- 102 days
- Class
- Class II
- Product code
- DXZ
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 5 generations to K921895 (1992). 24 ancestors in all, the oldest K830889 (1983). 11 later devices descend from it, 5 citing it directly.
- Root · 5 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 4 generations backK961810 Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 3 generations backK980431 SurgisisCook Biotech, Inc. · 1998
- 2 generations backK020455 Tissuemend Soft Tissue Repair MatrixTei Biosciences, Inc. · 2002
- 1 generation backK051405 Regensis Pericardial PatchCormatrix Cardiovascular, Inc. · 2005
- This deviceK063349 Cormatrix Patch for Cardiac Tissue RepairCormatrix Cardiovascular, Inc. · 2007
- Descendant · cites it directly · 4 of its ownK140306 Cormatrix Protect Ecm EnvelopeCormatrix Cardiovascular, Inc. · 2014 · Recalled
- Descendant · 2 generations on · 3 of its ownK173242 CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo…Aziyo Biologics, Inc. · 2017 · Recalled
- Descendant · 3 generations on · 2 of its ownK182255 CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium)…Aziyo Biologics, Inc. · 2018 · Recalled
- Descendant · cites it directly · 2 of its ownK152127 CorMatrix TykeCormatrix Cardiovascular, Inc. · 2016
- Descendant · 4 generations on · 1 of its ownK192616 CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo…Aziyo Biologics, Inc. · 2019
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K140306Cormatrix Protect Ecm EnvelopeCormatrix Cardiovascular, Inc. · 2014 · cites it directly4descendants
- K173242CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc. · 2017 · 2 generations on3descendants
- K182255CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo Neuro…Aziyo Biologics, Inc. · 2018 · 3 generations on2descendants
- K152127CorMatrix TykeCormatrix Cardiovascular, Inc. · 2016 · cites it directly2descendants
- K192616CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc. · 2019 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K921895 | Tissue Patch, Tissue Graft | Bio-Vascular, Inc. | 1992 | — |
| −4 | K961810 | Supple Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −3 | K980431 | Surgisis | Cook Biotech, Inc. | 1998 | — |
| −2 | K020455 | Tissuemend Soft Tissue Repair Matrix | Tei Biosciences, Inc. | 2002 | — |
| −1 | K051405 | Regensis Pericardial Patch | Cormatrix Cardiovascular, Inc. | 2005 | — |
| 0 (this device) | K063349 | Cormatrix Patch for Cardiac Tissue Repair | Cormatrix Cardiovascular, Inc. | 2007 | — |
| +1 | K140306 | Cormatrix Protect Ecm Envelope | Cormatrix Cardiovascular, Inc. | 2014 | 2 |
| +2 | K173242 | CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope… | Aziyo Biologics, Inc. | 2017 | 1 |
| +3 | K182255 | CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo… | Aziyo Biologics, Inc. | 2018 | 1 |
| +1 | K152127 | CorMatrix Tyke | Cormatrix Cardiovascular, Inc. | 2016 | — |
| +4 | K192616 | CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope… | Aziyo Biologics, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1985 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 5 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DXZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DXZ device
- #1 K240775 PeriBeam® Pericardial Membranescore 9.2 · 1 generation · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (7)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K980431 | SurgisisSummary page 2…C. 510(k) PREMARKET NOTIFICATION PREDICATE DEVICES * Cook Biotech, Inc., SurgiSIS Surgical Mesh (K980431) * CorMatrix Cardiovascular, Inc., CorMatrix Patch for Pericardial Closure (K051405) * Peritec Biosciences LT… | 1998 |
| * | K051405 | Regensis Pericardial PatchSummary page 2…PREDICATE DEVICES * Cook Biotech, Inc., SurgiSIS Surgical Mesh (K980431) * CorMatrix Cardiovascular, Inc., CorMatrix Patch for Pericardial Closure (K051405) * Peritec Biosciences LTD, PFA Vascular Patch (K041736) * Shelhigh, Shelhigh No-React VASCUPATCH (K9828 10) *… | 2005 |
| * | K041736 | Pfa PatchSummary page 2…cal Mesh (K980431) * CorMatrix Cardiovascular, Inc., CorMatrix Patch for Pericardial Closure (K051405) * Peritec Biosciences LTD, PFA Vascular Patch (K041736) * Shelhigh, Shelhigh No-React VASCUPATCH (K9828 10) * Bio-Vascular, Inc., CV Peri-Guard Cardiovascular Patch (K98360… | 2005 |
| * | K982810 | Shelhigh NO-React VascupatchSummary page 2…, CorMatrix Patch for Pericardial Closure (K051405) * Peritec Biosciences LTD, PFA Vascular Patch (K041736) * Shelhigh, Shelhigh No-React VASCUPATCH (K9828 10) * Bio-Vascular, Inc., CV Peri-Guard Cardiovascular Patch (K983602) · Synovis Surgical Innovations, Peri-Strips Stapl… | 1998 |
| * | K983602 | CV Peri-Guard and Vascu-GuardSummary page 2…c Biosciences LTD, PFA Vascular Patch (K041736) * Shelhigh, Shelhigh No-React VASCUPATCH (K9828 10) * Bio-Vascular, Inc., CV Peri-Guard Cardiovascular Patch (K983602) · Synovis Surgical Innovations, Peri-Strips Staple Line Reinforcement (K040415) * Boston Scientific Corp., PTFE Felt… | 1998 |
| * | K040415 | Peri-Strips Staple Line Reinforcement - Sleeve and Strip Configurations - and…Summary page 2…SCUPATCH (K9828 10) * Bio-Vascular, Inc., CV Peri-Guard Cardiovascular Patch (K983602) · Synovis Surgical Innovations, Peri-Strips Staple Line Reinforcement (K040415) * Boston Scientific Corp., PTFE Felts and Pledgets (K041716) INTENDED USE The CorMatrix Patch for Cardiac Tissue Repair i… | 2004 |
| * | K041716 | Ptfe Felts and PledgetsSummary page 2…ovascular Patch (K983602) · Synovis Surgical Innovations, Peri-Strips Staple Line Reinforcement (K040415) * Boston Scientific Corp., PTFE Felts and Pledgets (K041716) INTENDED USE The CorMatrix Patch for Cardiac Tissue Repair is intended for use as an intracardiac patch or pledget for tissue r… | 2004 |
What descends from it? (11)
See all 115 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 4 companies; a new generation was cleared every 3.4 years on median.
- 3 of the 24 ancestors have a recall of any class.
- Of its descendants, K140306 (Cormatrix Cardiovascular, Inc., 2014) has gone furthest, with 4 descendants of its own.
- 28 other devices also cite its predicate K980431.
How does its category compare?
All DXZ devicesDXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · DXZ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXZ
106in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXZ
2in 2025
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · DXZ
119in 2025
MAUDE reports naming product code DXZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 50 |
| 2008 | 2 | — | 0 | 6 |
| 2009 | 1 | — | 0 | 109 |
| 2010 | 3 | 91 | 2 | 81 |
| 2011 | 2 | — | 2 | 47 |
| 2012 | 1 | — | 0 | 21 |
| 2013 | 1 | — | 2 | 69 |
| 2014 | 3 | 106 | 0 | 93 |
| 2015 | 2 | — | 0 | 171 |
| 2016 | 2 | — | 0 | 66 |
| 2017 | 1 | — | 0 | 30 |
| 2018 | 0 | — | 1 | 44 |
| 2019 | 0 | — | 0 | 55 |
| 2020 | 1 | — | 1 | 121 |
| 2021 | 0 | — | 0 | 80 |
| 2022 | 0 | — | 0 | 77 |
| 2023 | 0 | — | 2 | 40 |
| 2024 | 0 | — | 0 | 49 |
| 2025 | 1 | — | 2 (2) | 119 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The CorMatrix® Patch for Cardiac Tissue Repair is indicated for use as an intracardiac patch or pledget for tissue repair (i.e., arterial septal defect (ASD), ventricular septal defect (VSD), etc.) and suture-line buttressing.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063349 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063349: Cormatrix Patch for Cardiac Tissue Repair.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063349
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026