# K163231: Chameleon PTA Balloon Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Av Medical Technologies, Ltd.
- Decided: Jan 17, 2017 after 61 days
- Product code: LIT (Catheter, Angioplasty, Peripheral, Transluminal)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K014212 (2002). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151678: Chameleon PTA Balloon Catheter, Av Medical Technologies, Ltd. (2015) Summary page 4.
- K152625: MMS Guide Catheter, Micro Medical Solutions, Inc. (2016) Summary page 4.

## Most influential descendants
- K170635: Chameleon PTA Balloon Catheter (2017), 0 descendants of its own

## Recalls of this device
- Sep 19, 2024 · Class II · Z-0257-2025: Specific lots of the Chameleon PTA Balloon Catheter failed to meet in-house balloon pressure testing.
- Dec 17, 2021 · Class II · Z-0557-2022: The firm has received six (6) complaint reports from customers indicating difficulty removing the balloon protector sleeve from the catheter (e.g., excessive force required to remove the protector sle

## 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/K163231
Methodology: https://510kreport.com/methodology