# K152665: PolarCath Peripheral Dilatation System

- Pathway: 510(k) (Traditional)
- Applicant: Nucyro Vascular, LLC
- Decided: Oct 26, 2015 after 39 days
- Product code: LIT (Catheter, Angioplasty, Peripheral, Transluminal)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K092455 (2009). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092455: Modification to: Polarcath Peripheral Dilatation System, Boston Scientific Corporation (2009) Summary page 5.

## Recalls of this device
- Oct 11, 2019 · Class II · Z-0507-2020: Peripheral Dilation Catheters that were E-Beam Sterilized were inadvertently mislabeled with EO sterilized labels.

## Indications for use
The PolarCath Peripheral Dilatation System's intended use is for the dilatation of stenoses in the peripheral vasculature (iliac, femoral, popliteal, infrapopliteal, renal and subclavian arteries) and for the treatment of obstructive lesions of polytetrafluoroethylene (PTFE) access grafts or native arteriovenous dialysis fistulae. The PolarCath Peripheral Dilatation System is also indicated for post-deployed stent expansion of self-expanding peripheral vascular stents.

Source page: https://510kreport.com/device/K152665
Methodology: https://510kreport.com/methodology