HEMASHIELD MICROVEL/WOVEN DOUBLE VELOUR FABRIC— 510(k) K931386

Unknown

Meadox Medicals, Div. Boston Scientific Corp.

FDA 510(k) clearance K931386 for HEMASHIELD MICROVEL/WOVEN DOUBLE VELOUR FABRIC, Unknown on 1993-05-27. Applicant: Meadox Medicals, Div. Boston Scientific Corp..

Clearance details

Applicant: Meadox Medicals, Div. Boston Scientific Corp.
Product code: Code DXZ
Advisory panel: Cardiovascular
Date received: 1993-03-18
Decision date: 1993-05-27
Decision: Unknown
Clearance type: Traditional
Location: Oakland, NJ, 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.