PolarCath Peripheral Dilatation System— 510(k) K152665
Substantially EquivalentNucyro Vascular, LLC
FDA 510(k) clearance K152665 for PolarCath Peripheral Dilatation System, Substantially Equivalent on 2015-10-26. Applicant: Nucyro Vascular, LLC. Device class: 2.
Clearance details
- Applicant
- Nucyro Vascular, LLC
- Product code
- Code LIT
- Device class
- Class 2
- Regulation
- 21 CFR 870.1250
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sunnyvale, CA, US
Recent devices under product code LIT
view allAdverse events under product code LIT
product code LIT- Death
- 27
- Injury
- 1,256
- Malfunction
- 12,127
- Total
- 13,410
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K152665
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K152665.
Data sourced from openFDA. This site is unofficial and independent of the FDA.