510(k) · Cleared
ClearedCormatrix Ecm for Vascular 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 Jul 15, 2014 as substantially equivalent to K983602 (Bio-Vascular, Inc., 1998) and 3 other predicates after a 106-day review. Its family tree reaches back 7 generations to 1992.
- Decided
- Jul 15, 2014
- Review
- 106 days
- Class
- Class II
- Product code
- DXZ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 7 generations to K921895 (1992). 29 ancestors in all, the oldest K830889 (1983). No later device cites it as a predicate yet.
- Root · 7 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 6 generations backK961810 Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 5 generations backK980431 SurgisisCook Biotech, Inc. · 1998
- 4 generations backK020455 Tissuemend Soft Tissue Repair MatrixTei Biosciences, Inc. · 2002
- 3 generations backK051405 Regensis Pericardial PatchCormatrix Cardiovascular, Inc. · 2005
- 2 generations backK063349 Cormatrix Patch for Cardiac Tissue RepairCormatrix Cardiovascular, Inc. · 2007
- 1 generation backK111187 Patch, Pledget and IntracardiacCormatrix Cardiovascular, Inc. · 2011
- This deviceK140789 Cormatrix Ecm for Vascular RepairCormatrix Cardiovascular, Inc. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K921895 | Tissue Patch, Tissue Graft | Bio-Vascular, Inc. | 1992 | — |
| −6 | K961810 | Supple Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −5 | K980431 | Surgisis | Cook Biotech, Inc. | 1998 | — |
| −4 | K020455 | Tissuemend Soft Tissue Repair Matrix | Tei Biosciences, Inc. | 2002 | — |
| −3 | K051405 | Regensis Pericardial Patch | Cormatrix Cardiovascular, Inc. | 2005 | — |
| −2 | K063349 | Cormatrix Patch for Cardiac Tissue Repair | Cormatrix Cardiovascular, Inc. | 2007 | — |
| −1 | K111187 | Patch, Pledget and Intracardiac | Cormatrix Cardiovascular, Inc. | 2011 | — |
| 0 (this device) | K140789 | Cormatrix Ecm for Vascular Repair | Cormatrix Cardiovascular, Inc. | 2014 | — |
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 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 5 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 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? (4)
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 |
|---|---|---|---|
| * | K983602 | CV Peri-Guard and Vascu-GuardSummary page 1…Predicate Devices The CorMatrixO ECMO for Vascular Repair is substantially equivalent to the following devices: " Synovis® Vascu-GuardO Peripheral Vascular Patch, K983602 * CarMatrix ECMV for Carotid Repair, K111187 * Cook® Biotech SurgisisO Peripheral Vascular Patch, K001785 *… | 1998 |
| * | K111187 | Patch, Pledget and IntracardiacSummary page 1…epair is substantially equivalent to the following devices: " Synovis® Vascu-GuardO Peripheral Vascular Patch, K983602 * CarMatrix ECMV for Carotid Repair, K111187 * Cook® Biotech SurgisisO Peripheral Vascular Patch, K001785 * CorMatrix ECM for Cardiac Tissue Repair, K063349 In… | 2011 |
| * | K001785 | Surgisis Peripheral Vascular PatchSummary page 1…Synovis® Vascu-GuardO Peripheral Vascular Patch, K983602 * CarMatrix ECMV for Carotid Repair, K111187 * Cook® Biotech SurgisisO Peripheral Vascular Patch, K001785 * CorMatrix ECM for Cardiac Tissue Repair, K063349 Indications for Use The CorMatrixe ECM®I for Vascular Repair is intend… | 2000 |
| * | K063349 | Cormatrix Patch for Cardiac Tissue RepairSummary page 1…* CarMatrix ECMV for Carotid Repair, K111187 * Cook® Biotech SurgisisO Peripheral Vascular Patch, K001785 * CorMatrix ECM for Cardiac Tissue Repair, K063349 Indications for Use The CorMatrixe ECM®I for Vascular Repair is intended for use as a patch material for repair and reconstructi… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
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 22 years and passes through 4 companies; a new generation was cleared every 3.4 years on median.
- 5 of the 29 ancestors have a recall of any class.
- 9 other devices also cite its predicate K983602.
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. 2014, 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 ECM for Vascular Repair is intended for use as a patch material for repair and reconstruction of peripheral vasculature including the carotid, renal, iliac, femoral, and tibial blood vessels. The CorMatrix ECM for Vascular Repair may be used for patch closure of vessels, as a pledget, or for suture line buttressing when repairing peripheral vessels.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140789 · printed Nov 4, 2026
Cite this page
510(k) Report. “K140789: Cormatrix Ecm for Vascular Repair.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K140789
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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