ULTRASCORE Focused Force PTA Balloon— 510(k) K172571

Substantially Equivalent

C. R. Bard

FDA 510(k) clearance K172571 for ULTRASCORE Focused Force PTA Balloon, Substantially Equivalent on 2017-09-22. Applicant: C. R. Bard.

Clearance details

Applicant: C. R. Bard
Product code: Code PNO
Advisory panel: Cardiovascular
Date received: 2017-08-28
Decision date: 2017-09-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Tempe, AZ, 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.