SWIRLGRAFT VASCULAR ACCESS GRAFT— 510(k) K060741

Substantially Equivalent

Veryan Medical Limited

FDA 510(k) clearance K060741 for SWIRLGRAFT VASCULAR ACCESS GRAFT, Substantially Equivalent on 2006-04-05. Applicant: Veryan Medical Limited.

Clearance details

Applicant: Veryan Medical Limited
Product code: Code DSY
Advisory panel: Cardiovascular
Date received: 2006-03-20
Decision date: 2006-04-05
Decision: Substantially Equivalent
Clearance type: Special
Location: Gambrills, MD, 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.