INTERGARD HEMABRIDGE COLLAGEN COATED VASCULAR PROSTHESIS, INTERGARD AORTIC ARCH COLLAGEN COATED VASCULAR PROSTHESIS— 510(k) K013651

Substantially Equivalent

Intervascular

FDA 510(k) clearance K013651 for INTERGARD HEMABRIDGE COLLAGEN COATED VASCULAR PROSTHESIS, INTERGARD AORTIC ARCH COLLAGEN COATED VASCULAR PROSTHESIS, Substantially Equivalent on 2002-02-27. Applicant: Intervascular.

Clearance details

Applicant: Intervascular
Product code: Code DSY
Advisory panel: Cardiovascular
Date received: 2001-11-06
Decision date: 2002-02-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wellesley, MA, 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.