Angioplasty balloons

Chameleon

by Mozarc Medical US LLC

A sterile, non-drug-eluting, flexible tube designed for percutaneous transluminal angioplasty (PTA) to dilate a stenotic peripheral (i.e., non-cerebral, non-coronary) artery by controlled inflation of a distensible balloon(s) at its distal tip; it may also be intended for positioning and expansion of a stent/stent-graft. It is available as an over-the-wire (OTW) type with multiple lumens, or a rapid exchange (RX) type with a single lumen. Some types may include cutting/scoring elements (e.g., microsurgical blades, dual wire configurations) to score/modify the plaque. This is a single-use device.

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Where to buy Chameleon

Contact Mozarc Medical US LLC directly; they can quote, ship, or point you to the distributor for your country.

From mozarcmedical.com, checked October 2026.

No reply, or outside their markets? Send us a request and we route it to a rep or distributor for your country.

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Chameleon models and sizes

From the FDA Global Unique Device Identification Database. Confirm with the manufacturer's instructions for use.

Model / catalog no.SizeMRIStatus
CH05-40-75USOuter Diameter 5 mm; Catheter Gauge 5.9 Fr; Length 40 mm Not statedAvailable
CH06-40-75USCatheter Gauge 5.9 Fr; Outer Diameter 6 mm; Length 40 mm Not statedAvailable
CH07-40-75USLength 40 mm; Catheter Gauge 5.9 Fr; Outer Diameter 7 mm Not statedAvailable
CH08-40-75USOuter Diameter 8 mm; Catheter Gauge 5.9 Fr; Length 40 mm Not statedAvailable
CH09-40-75USOuter Diameter 9 mm; Catheter Gauge 5.9 Fr; Length 40 mm Not statedAvailable
CH10-40-75USOuter Diameter 10 mm; Catheter Gauge 5.9 Fr; Length 40 mm Not statedAvailable
CH12-40-75USCatheter Gauge 5.9 Fr; Outer Diameter 12 mm; Length 40 mm Not statedAvailable

FDA clearances

  • 510(k) K170635 March 2017

Procedures that use angioplasty balloons

Frequently asked questions

What is Chameleon used for?

A sterile, non-drug-eluting, flexible tube designed for percutaneous transluminal angioplasty (PTA) to dilate a stenotic peripheral (i.e., non-cerebral, non-coronary) artery by controlled inflation of a distensible balloon(s) at its distal tip; it may also be intended for positioning and expansion of a stent/stent-graft. It is available as an over-the-wire (OTW) type with multiple lumens, or a rapid exchange (RX) type with a single lumen. Some types may include cutting/scoring elements (e.g., microsurgical blades, dual wire configurations) to score/modify the plaque. This is a single-use device.

Who makes Chameleon?

Chameleon is made by Mozarc Medical US LLC. It is listed under peripheral angioplasty balloons in our device library.

What sizes does Chameleon come in?

Sizes listed for Chameleon: Outer Diameter: 5–12 mm; Catheter Gauge: 5.9 Fr; Length: 40 mm. Confirm availability with the manufacturer's instructions for use.

Is Chameleon MRI safe?

The FDA device database entry for Chameleon does not state its MRI safety status. Check the labeling before MRI.

Is Chameleon FDA cleared?

Chameleon is covered by FDA submission K170635.

How do I contact a Mozarc Medical US LLC sales representative?

Mozarc Medical US LLC has not listed representatives on LA Vascular yet. Visit the Mozarc Medical US LLC company page for contact details.

Models, sizes and MRI status come from the FDA Global Unique Device Identification Database (GUDID); descriptions marked "provided by the manufacturer" are reviewed before publishing. Not an endorsement; follow the manufacturer's instructions for use.

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