ADVANCED CARDIOVASCULAR BALLOON DILATA— 510(k) K842556

Substantially Equivalent

Advanced Cardiovascular Systems, Inc.

FDA 510(k) clearance K842556 for ADVANCED CARDIOVASCULAR BALLOON DILATA, Substantially Equivalent on 1984-08-10. Applicant: Advanced Cardiovascular Systems, Inc..

Clearance details

Applicant: Advanced Cardiovascular Systems, Inc.
Product code: Code LIT
Advisory panel: Cardiovascular
Date received: 1984-07-02
Decision date: 1984-08-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LIT

product code LIT

Death: 27
Injury: 1,256
Malfunction: 12,127
Total: 13,410

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.