ULTRA LOW POROSITY DACRON WOVEN PATCH— 510(k) K921659

Unknown

Intervascular, Inc.

FDA 510(k) clearance K921659 for ULTRA LOW POROSITY DACRON WOVEN PATCH, Unknown on 1992-11-25. Applicant: Intervascular, Inc..

Clearance details

Applicant: Intervascular, Inc.
Product code: Code DXZ
Advisory panel: Cardiovascular
Date received: 1992-04-07
Decision date: 1992-11-25
Decision: Unknown
Clearance type: Traditional
Location: Clearwater, FL, 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.