ANGIOSCULPT PTA SCORING BALLOON CATHETER— 510(k) K122685

Substantially Equivalent

Angioscore, Inc.

FDA 510(k) clearance K122685 for ANGIOSCULPT PTA SCORING BALLOON CATHETER, Substantially Equivalent on 2013-01-11. Applicant: Angioscore, Inc..

Clearance details

Applicant: Angioscore, Inc.
Product code: Code PNO
Advisory panel: Cardiovascular
Date received: 2012-08-31
Decision date: 2013-01-11
Decision: Substantially Equivalent
Clearance type: Traditional
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.