Cormatrix Cardiovascular, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Cormatrix Cardiovascular, Inc.” (first 2005, latest 2018), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 106 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 2 | 148 |
| 2015 | 0 | — |
| 2016 | 1 | 188 |
| 2017 | 0 | — |
| 2018 | 1 | 174 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Cormatrix Cardiovascular, Inc. took a median 174 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 120 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DXZ | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene | 5 | 5 |
| FTM | Mesh, Surgical | 1 | 1 |
| PSQ | Intracardiac Patch Or Pledget, Biologically Derived | 1 | 1 |
Review panels
Most recent Cormatrix Cardiovascular, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K181038 | CorMatrix Cor Patch (3 cm x 5 cm)(single pack), CorMatrix Cor Patch (4 cm x 7 cm)(single pack), CorMatrix Cor Patch (7 cm x 10 cm)(single pack) | PSQ | 2018-10-10 | 174 |
| K152127 | CorMatrix Tyke | DXZ | 2016-02-04 | 188 |
| K140306 | CORMATRIX PROTECT ECM ENVELOPE | FTM | 2014-08-15 | 189 |
| K140789 | CORMATRIX ECM FOR VASCULAR REPAIR | DXZ | 2014-07-15 | 106 |
| K111187 | PATCH, PLEDGET AND INTRACARDIAC | DXZ | 2011-07-26 | 90 |
| K063349 | CORMATRIX PATCH FOR CARDIAC TISSUE REPAIR | DXZ | 2007-02-16 | 102 |
| K051405 | REGENSIS PERICARDIAL PATCH | DXZ | 2005-08-31 | 92 |
Recalls
openFDA lists no recalls under a recalling firm named Cormatrix Cardiovascular, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Cormatrix Cardiovascular, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Cormatrix Cardiovascular, Inc.” (first 2005, latest 2018), across 3 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Cormatrix Cardiovascular, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cormatrix Cardiovascular, Inc. is 106 days.
Which FDA product codes appear under Cormatrix Cardiovascular, Inc.?
The most frequent FDA product codes under this applicant name are DXZ (Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene, 5); FTM (Mesh, Surgical, 1); PSQ (Intracardiac Patch Or Pledget, Biologically Derived, 1).
Next steps
- See all 7 Cormatrix Cardiovascular, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DXZ, Cormatrix Cardiovascular, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.