# K170635: Chameleon PTA Balloon Catheter

- Pathway: 510(k) (Special)
- Applicant: Av Medical Technologies, Ltd.
- Decided: Mar 30, 2017 after 28 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: 7 generations back to K014212 (2002). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163231: Chameleon PTA Balloon Catheter, Av Medical Technologies, Ltd. (2017) Summary page 4.

## Indications for use
The Chameleon PTA Balloon Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the femoral, iliac, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The Chameleon enables the infusion of diagnostic or therapeutic fluids. This catheter is not for use in coronary arteries or cerebral vasculature.

Source page: https://510kreport.com/device/K170635
Methodology: https://510kreport.com/methodology