SPIRAL LAMINAR FLOW VASCULAR ARTERIOVENOUS GRAFT— 510(k) K094044

Substantially Equivalent

Tayside Flow Technologies Limited

FDA 510(k) clearance K094044 for SPIRAL LAMINAR FLOW VASCULAR ARTERIOVENOUS GRAFT, Substantially Equivalent on 2010-03-23. Applicant: Tayside Flow Technologies Limited.

Clearance details

Applicant: Tayside Flow Technologies Limited
Product code: Code DSY
Advisory panel: Cardiovascular
Date received: 2009-12-31
Decision date: 2010-03-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chandler, AZ, 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.