EXXCEL AND EXXCEL SOFT EPTFE VASCULAR GRAFTS, MICROVEL DOUBLE VELOUR KNITTED VASCULAR GRAFTS, WOVEN DOUBLE VELOUR WOVEN— 510(k) K052964

Substantially Equivalent

Boston Scientific Corp

FDA 510(k) clearance K052964 for EXXCEL AND EXXCEL SOFT EPTFE VASCULAR GRAFTS, MICROVEL DOUBLE VELOUR KNITTED VASCULAR GRAFTS, WOVEN DOUBLE VELOUR WOVEN, Substantially Equivalent on 2006-01-06. Applicant: Boston Scientific Corp.

Clearance details

Applicant: Boston Scientific Corp
Product code: Code DSY
Advisory panel: Cardiovascular
Date received: 2005-10-21
Decision date: 2006-01-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Maple Grove, MN, US

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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.