AngioSculpt PTA Scoring Balloon Catheter with HydroCross Coating— 510(k) K142983

Substantially Equivalent

Angioscore, Inc.

FDA 510(k) clearance K142983 for AngioSculpt PTA Scoring Balloon Catheter with HydroCross Coating, Substantially Equivalent on 2015-03-04. Applicant: Angioscore, Inc..

Clearance details

Applicant: Angioscore, Inc.
Product code: Code PNO
Advisory panel: Cardiovascular
Date received: 2014-10-16
Decision date: 2015-03-04
Decision: Substantially Equivalent
Clearance type: Special
Location: Fremont, CA, US

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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.