REGENSIS PERICARDIAL PATCH— 510(k) K051405

Substantially Equivalent

Cormatrix Cardiovascular, Inc.

FDA 510(k) clearance K051405 for REGENSIS PERICARDIAL PATCH, Substantially Equivalent on 2005-08-31. Applicant: Cormatrix Cardiovascular, Inc..

Clearance details

Applicant: Cormatrix Cardiovascular, Inc.
Product code: Code DXZ
Advisory panel: Cardiovascular
Date received: 2005-05-31
Decision date: 2005-08-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

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Adverse events under product code DXZ

product code DXZ

Death: 19
Injury: 265
Total: 284

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.