OCHSNER & MICRON FABRIC PATCH— 510(k) K881508

Substantially Equivalent

Intervascular, Inc.

FDA 510(k) clearance K881508 for OCHSNER & MICRON FABRIC PATCH, Substantially Equivalent on 1988-05-25. Applicant: Intervascular, Inc..

Clearance details

Applicant: Intervascular, Inc.
Product code: Code DXZ
Advisory panel: Cardiovascular
Date received: 1988-04-11
Decision date: 1988-05-25
Decision: Substantially Equivalent
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.