# K092455: Modification to: Polarcath Peripheral Dilatation System

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corporation
- Decided: Sep 4, 2009 after 25 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) PolarCath Peripheral Dilatation System: named in the summary without a submission number

## Most influential descendants
- K152665: PolarCath Peripheral Dilatation System (2015), 0 descendants of its own

## 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 rlolytetrafluoroethylene (PTFE) access grafts or native arteriovenous dialysis Iistulae. The PolarCath Peripheral Dilatation System is also indicated for post-deployed stent expansion of self-expanding peripheral vascular stErnts.

Source page: https://510kreport.com/device/K092455
Methodology: https://510kreport.com/methodology