SPIRAL FLOW VASCULAR ARTERIOVENOUS GRAFT— 510(k) K141124

Substantially Equivalent

Vascular Flow Technologies, Ltd.

FDA 510(k) clearance K141124 for SPIRAL FLOW VASCULAR ARTERIOVENOUS GRAFT, Substantially Equivalent on 2014-05-30. Applicant: Vascular Flow Technologies, Ltd..

Clearance details

Applicant: Vascular Flow Technologies, Ltd.
Product code: Code DSY
Advisory panel: Cardiovascular
Date received: 2014-05-01
Decision date: 2014-05-30
Decision: Substantially Equivalent
Clearance type: Special
Location: Dundee, GB

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.