ANGIOSCULPT PTA SCORING BALLOON CATHETER MODEL 2039-XXYY, 2076-XXYY, 2092-XXYY, 2105-XXYY— 510(k) K100303

Substantially Equivalent

Angioscore, Inc.

FDA 510(k) clearance K100303 for ANGIOSCULPT PTA SCORING BALLOON CATHETER MODEL 2039-XXYY, 2076-XXYY, 2092-XXYY, 2105-XXYY, Substantially Equivalent on 2010-03-22. Applicant: Angioscore, Inc..

Clearance details

Applicant: Angioscore, Inc.
Product code: Code PNO
Advisory panel: Cardiovascular
Date received: 2010-02-03
Decision date: 2010-03-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fremont, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code PNO

product code PNO

Malfunction: 1,646
Total: 1,646

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.