# K042230: Polarcath Peripheral Balloon Catheter System

- Pathway: 510(k) (Traditional)
- Applicant: Cryo Vascular Systems, Inc.
- Decided: Nov 5, 2004 after 80 days
- Product code: DQY (Catheter, Percutaneous)
- 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.
No later device cites it as a predicate yet.
0 of 1 device 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 Balloon Catheter System: named in the summary without a submission number

## Indications for use
The PolarCathTM Peripheral Dilatation System is indicated to dilate stenosis in the peripheral vasculature (subclavian, renal, iliac, femoral, popliteal, and infrapopliteal 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 in self-expanding peripheral vascular stents.

Source page: https://510kreport.com/device/K042230
Methodology: https://510kreport.com/methodology