# K030742: Polarcath Peripheral Balloon Catheter System

- Pathway: 510(k) (Traditional)
- Applicant: Cryo Vascular Systems, Inc.
- Decided: Aug 29, 2003 after 172 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.
8 later devices descend from it; 3 cite it directly.
0 of 9 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 Balloon Catheter System: named in the summary without a submission number
- (no number) RX Viatrac 14 Peripheral Dilatation Catheter: named in the summary without a submission number
- (no number) Vantage Dilatation Catheter: named in the summary without a submission number
- (no number) Cook PTA Balloon Catheter: named in the summary without a submission number

## Most influential descendants
- K040155: Peripheral Cutting Balloon (2004), 6 descendants of its own
- K051254: Peripheral Cutting Balloon (2005), 5 descendants of its own
- K041993: 2 CM Peripheral Cutting Baloon (2004), 5 descendants of its own
- K052038: Peripheral Cutting Balloon Small Monorail or Over-the-Wire Delivery System (2005), 4 descendants of its own
- K062387: Small Peripheral Cutting Ballon, Monorail Delivery System (2006), 3 descendants of its own

## 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/K030742
Methodology: https://510kreport.com/methodology