VASCUTEK VASCUSOFT PLUS VASCULAR GRAFT— 510(k) K960706

Unknown

Carbomedics, Inc.

FDA 510(k) clearance K960706 for VASCUTEK VASCUSOFT PLUS VASCULAR GRAFT, Unknown on 1996-04-25. Applicant: Carbomedics, Inc..

Clearance details

Applicant: Carbomedics, Inc.
Product code: Code DSY
Advisory panel: Cardiovascular
Date received: 1996-02-21
Decision date: 1996-04-25
Decision: Unknown
Clearance type: Traditional
Location: Austin, TX, 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.