PolarCath Peripheral Dilatation System— 510(k) K152665

Substantially Equivalent

Nucyro Vascular, LLC

FDA 510(k) clearance K152665 for PolarCath Peripheral Dilatation System, Substantially Equivalent on 2015-10-26. Applicant: Nucyro Vascular, LLC.

Clearance details

Applicant: Nucyro Vascular, LLC
Product code: Code LIT
Advisory panel: Cardiovascular
Date received: 2015-09-17
Decision date: 2015-10-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LIT

product code LIT

Death: 27
Injury: 1,256
Malfunction: 12,127
Total: 13,410

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.