ADVANCED CARDIOVASCULAR SYSTEMS HEMOSTATIC VALVES— 510(k) K854261

Substantially Equivalent

Advanced Cardiovascular Systems, Inc.

FDA 510(k) clearance K854261 for ADVANCED CARDIOVASCULAR SYSTEMS HEMOSTATIC VALVES, Substantially Equivalent on 1985-12-04. Applicant: Advanced Cardiovascular Systems, Inc..

Clearance details

Applicant: Advanced Cardiovascular Systems, Inc.
Product code: Code DTL
Advisory panel: Cardiovascular
Date received: 1985-10-23
Decision date: 1985-12-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain View, CA, 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.