CorMatrix Tyke— 510(k) K152127
Substantially EquivalentCormatrix Cardiovascular, Inc.
FDA 510(k) clearance K152127 for CorMatrix Tyke, Substantially Equivalent on 2016-02-04. Applicant: Cormatrix Cardiovascular, Inc.. Device class: 2.
Clearance details
- Applicant
- Cormatrix Cardiovascular, Inc.
- Product code
- Code DXZ
- Device class
- Class 2
- Regulation
- 21 CFR 870.3470
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Roswell, GA, US
Recent devices under product code DXZ
view allMore clearances from Cormatrix Cardiovascular, Inc.
view all- 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)
- K140306 — CORMATRIX PROTECT ECM ENVELOPE
- K140789 — CORMATRIX ECM FOR VASCULAR REPAIR
- K111187 — PATCH, PLEDGET AND INTRACARDIAC
- K063349 — CORMATRIX PATCH FOR CARDIAC TISSUE REPAIR
Adverse events under product code DXZ
product code DXZ- Death
- 19
- Injury
- 265
- Total
- 284
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.