# K042541: Modification to Polarcath Peripheral Dilatation System

- Pathway: 510(k) (Special)
- Applicant: Cryo Vascular Systems, Inc.
- Decided: Oct 12, 2004 after 22 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 Dilatation System: named in the summary without a submission number

## Indications for use
The PolarCath Peripheral Dilatation System is indicated to dilate stenosis in the peripheral vasculature (iliac, femoral, popliteal, infrapopliteal, and renal arteries) and for the treatment of obstructive lesions of PTFE access grafts or native arteriovenous dialysis fistulae.

Source page: https://510kreport.com/device/K042541
Methodology: https://510kreport.com/methodology