EPTFE SLFTM SPIRAL VASCULAR GRAFT— 510(k) K083169

Substantially Equivalent

Tayside Flow Technologies Limited

FDA 510(k) clearance K083169 for EPTFE SLFTM SPIRAL VASCULAR GRAFT, Substantially Equivalent on 2009-03-30. Applicant: Tayside Flow Technologies Limited.

Clearance details

Applicant: Tayside Flow Technologies Limited
Product code: Code DSY
Advisory panel: Cardiovascular
Date received: 2008-10-27
Decision date: 2009-03-30
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.