SULZER VASCUTEK SEALPTFE VASCULAR PROSTHESIS— 510(k) K993667

Substantially Equivalent

Sulzermedica

FDA 510(k) clearance K993667 for SULZER VASCUTEK SEALPTFE VASCULAR PROSTHESIS, Substantially Equivalent on 2000-01-28. Applicant: Sulzermedica.

Clearance details

Applicant: Sulzermedica
Product code: Code DSY
Advisory panel: Cardiovascular
Date received: 1999-11-01
Decision date: 2000-01-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

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.