CARDIO-WRAP— 510(k) K090637

Unknown

Mast Biosurgery USA, Inc.

FDA 510(k) clearance K090637 for CARDIO-WRAP, Unknown on 2010-01-07. Applicant: Mast Biosurgery USA, Inc..

Clearance details

Applicant: Mast Biosurgery USA, Inc.
Product code: Code DXZ
Advisory panel: Cardiovascular
Date received: 2009-03-10
Decision date: 2010-01-07
Decision: Unknown
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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.