Chameleon

FDA UDI

Class II (US FDA UDI)

by Mozarc Medical US LLC

Identity

Trade Name: Chameleon FDA UDI
Generic Name: Peripheral angioplasty balloon catheter, basic FDA UDI
Device Name: PTA Balloon Catheter with Injection Port FDA UDI
Model / Reference: CH06-40-75US FDA UDI
Description: PTA Balloon Catheter with Injection Port FDA UDI

Identifiers

Primary DI / UDI-DI: 10884521812277 FDA UDI
FDA Product Code: LIT FDA UDI
KRA FDA UDI
GMDN Term: Peripheral angioplasty balloon catheter, basic FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.1250 FDA UDI
870.1210 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

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Serial Number

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Expiration Date

Yes

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Manufacturing Date

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Dimensions & Sizes

Size: Catheter Gauge — 5.9 French FDA UDI
Outer Diameter — 6 Millimeter FDA UDI
Length — 40 Millimeter FDA UDI

Category: Peripheral angioplasty balloon catheter, basic

The Chameleon peripheral angioplasty balloon catheter is a sterile, non-drug-eluting, flexible tube designed for percutaneous transluminal angioplasty (PTA) to dilate stenotic peripheral arteries. It features multiple lumens, a rapid exchange design, and cutting/scoring elements for plaque modification. As a single-use device, it is intended for use in the treatment of peripheral artery disease.

Similar devices

Also classified as Peripheral angioplasty balloon catheter, basic.

Minerva PTA Balloon Dilatation Catheter — BrosMed Medical Co., Ltd. · Class IIa
Advocate™ — Merit Medical Systems, Inc. · Class II
Senri — KANEKA Corporation · Class IIa
Jade PTA Balloon Dilatation Catheter — OrbusNeich Medical (ShenZhen) Co., Ltd. · Class II
ZENFluxion — Zylox-Tonbridge Medical Technology Co., Ltd. · Class III
Pacific™ Plus — MEDTRONIC, INC. · Class II
Metacross OTW — KANEKA Corporation · Class IIa
Armada — Abbott Vascular · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Mozarc Medical US LLC

Sources (1)

FDA UDI cf47ab8c-6474-4125-852d-f88dd181c277 36 fields · synced Oct 6, 2026