ACS ANGIOTRAK(TM) SYSTEM— 510(k) K921719

Substantially Equivalent

Advanced Cardiovascular Systems, Inc.

FDA 510(k) clearance K921719 for ACS ANGIOTRAK(TM) SYSTEM, Substantially Equivalent on 1992-08-07. Applicant: Advanced Cardiovascular Systems, Inc..

Clearance details

Applicant: Advanced Cardiovascular Systems, Inc.
Product code: Code MAV
Advisory panel: Cardiovascular
Date received: 1992-04-09
Decision date: 1992-08-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Temecula, CA, US

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Adverse events under product code MAV

product code MAV

Malfunction: 1,433
Total: 1,433

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.