ANGIOSCULPT PTA SCORING BALLOON CATHETER, MODELS 2076 AND 2039— 510(k) K080151

Substantially Equivalent

Angioscore, Inc.

FDA 510(k) clearance K080151 for ANGIOSCULPT PTA SCORING BALLOON CATHETER, MODELS 2076 AND 2039, Substantially Equivalent on 2008-04-25. Applicant: Angioscore, Inc..

Clearance details

Applicant: Angioscore, Inc.
Product code: Code PNO
Advisory panel: Cardiovascular
Date received: 2008-01-22
Decision date: 2008-04-25
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.