QUEST VEIN GRAFT PERFUSION SET— 510(k) K952531

Substantially Equivalent

Quest Medical, Inc.

FDA 510(k) clearance K952531 for QUEST VEIN GRAFT PERFUSION SET, Substantially Equivalent on 1995-08-24. Applicant: Quest Medical, Inc..

Clearance details

Applicant: Quest Medical, Inc.
Product code: Code DTL
Advisory panel: Cardiovascular
Date received: 1995-06-01
Decision date: 1995-08-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Allen, TX, US

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Adverse events under product code DTL

product code DTL

Malfunction: 770
Total: 770

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.