SULZER VASCUTEK GELSOFT ERS VASCULAR PROSTHESIS— 510(k) K002007

Substantially Equivalent

Sulzer Carbomedics, Inc.

FDA 510(k) clearance K002007 for SULZER VASCUTEK GELSOFT ERS VASCULAR PROSTHESIS, Substantially Equivalent on 2001-01-25. Applicant: Sulzer Carbomedics, Inc..

Clearance details

Applicant: Sulzer Carbomedics, Inc.
Product code: Code DSY
Advisory panel: Cardiovascular
Date received: 2000-07-03
Decision date: 2001-01-25
Decision: Substantially Equivalent
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.