ADVANCED CARDIOVASCULAR SYS LOW PROFILE PTA BALLOO— 510(k) K851854

Substantially Equivalent

Advanced Cardiovascular Systems, Inc.

FDA 510(k) clearance K851854 for ADVANCED CARDIOVASCULAR SYS LOW PROFILE PTA BALLOO, Substantially Equivalent on 1985-08-05. Applicant: Advanced Cardiovascular Systems, Inc..

Clearance details

Applicant: Advanced Cardiovascular Systems, Inc.
Product code: Code LIT
Advisory panel: Cardiovascular
Date received: 1985-04-26
Decision date: 1985-08-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain View, CA, 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.