Chameleon

Basic Information

• Brand Name: Chameleon
• Primary DI: 10884521812314
• Version / Model: CH10-40-75US
• Company Name: Covidien LP
• Labeler DUNS: 058614483
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-11-20
• Public Version: 3
• Public Version Date: 2023-07-12
• Public Version Status: Update
• Public Device Record Key: 5f4c56ae-0b45-4903-a99c-09e944953c8e

Device Description

PTA Balloon Catheter with Injection Port

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LIT	Catheter, angioplasty, peripheral, transluminal	Cardiovascular	870.1250	2
KRA	Catheter, continuous flush	Cardiovascular	870.1210	2

GMDN Terms

Code	Name	Definition	Implantable	Status
17184	Peripheral angioplasty balloon catheter, basic	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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10884521812314	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K170635	000

Device Sizes

Type	Value	Unit	Text
Outer Diameter	10	Millimeter
Catheter Gauge	5.9	French
Device Size Text, specify			Shaft Length, 75, CM;
Length	40	Millimeter

Storage Conditions

• Type: Handling Environment Atmospheric Pressure
• Temperature Range: – 1216 KiloPascal
• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry