# K071042: Polarcath Peripheral Dilatation System

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corp
- Decided: Jun 13, 2007 after 62 days
- Product code: LIT (Catheter, Angioplasty, Peripheral, Transluminal)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K062594 (2006). 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)
- K062594: Modification to Polarcath Peripheral Dilatation System, Boston Scientific Corporation (2006) Summary page 1.

## Indications for use
The PolarCathTM Peripheral Dilatation System is indicated to dilate 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 arteriovenous dialysis fistulae. The PolarCathTM Peripheral Dilatation System is also indicated for post-deployed stent expansion of self-expanding peripheral vascular stents.

Source page: https://510kreport.com/device/K071042
Methodology: https://510kreport.com/methodology