EXXCEL SOFT EPTEE VASCULAR GRAFT-STANDARD WALL,THIN WALL— 510(k) K113101

Substantially Equivalent

Boston Scientific Corporation

FDA 510(k) clearance K113101 for EXXCEL SOFT EPTEE VASCULAR GRAFT-STANDARD WALL,THIN WALL, Substantially Equivalent on 2012-01-17. Applicant: Boston Scientific Corporation.

Clearance details

Applicant: Boston Scientific Corporation
Product code: Code DSY
Advisory panel: Cardiovascular
Date received: 2011-10-19
Decision date: 2012-01-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wayne, NJ, 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.