MODIFICATION TO HEMASHIELD PLATINUM WOVEN/MICROVEL DOUBLE VELOUR VASCULAR GRAFTS— 510(k) K021213

Substantially Equivalent

Boston Scientific Corp

FDA 510(k) clearance K021213 for MODIFICATION TO HEMASHIELD PLATINUM WOVEN/MICROVEL DOUBLE VELOUR VASCULAR GRAFTS, Substantially Equivalent on 2002-04-19. Applicant: Boston Scientific Corp.

Clearance details

Applicant: Boston Scientific Corp
Product code: Code MAL
Advisory panel: Cardiovascular
Date received: 2002-04-17
Decision date: 2002-04-19
Decision: Substantially Equivalent
Clearance type: Special
Location: Natick,, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MAL

product code MAL

Death: 4
Total: 4

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.