PLASMA TFE SYNTHETIC ARTERY-CLARIFICATION— 510(k) K914116

Substantially Equivalent

Medtronic Vascular

FDA 510(k) clearance K914116 for PLASMA TFE SYNTHETIC ARTERY-CLARIFICATION, Substantially Equivalent on 1991-11-27. Applicant: Medtronic Vascular.

Clearance details

Applicant: Medtronic Vascular
Product code: Code DSY
Advisory panel: Cardiovascular
Date received: 1991-09-05
Decision date: 1991-11-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, 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.