HEMASHIELD GOLD WOVEN DOUBLE VELOUR VASCULAR GRAFT - BRANCH GRAFT— 510(k) K012952

Substantially Equivalent

Boston Scientific/Medi-Tech

FDA 510(k) clearance K012952 for HEMASHIELD GOLD WOVEN DOUBLE VELOUR VASCULAR GRAFT - BRANCH GRAFT, Substantially Equivalent on 2001-10-02. Applicant: Boston Scientific/Medi-Tech.

Clearance details

Applicant: Boston Scientific/Medi-Tech
Product code: Code DSY
Advisory panel: Cardiovascular
Date received: 2001-09-04
Decision date: 2001-10-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Natick,, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DSY

product code DSY

Death: 29
Injury: 694
Total: 723

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.