CVX-300-P

Basic Information

• Brand Name: CVX-300-P
• Primary DI: M204CVX300P0
• Version / Model: CVX-300-P
• Catalog Number: CVX-300-P
• Company Name: Spectranetics Corporation
• Labeler DUNS: 151047370
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-08-26
• Public Version: 6
• Public Version Date: 2023-07-28
• Public Version Status: Update
• Public Device Record Key: ba5f4c05-6086-4a13-9c9f-7efd5a6ccdc3

Device Description

Excimer Laser System

Device Characteristics

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LPC	Device, Angioplasty, Laser, Coronary	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
60389	Atherectomy excimer laser system	A mobile, mains electricity (AC-powered) Light Amplification by Stimulated Emission of Radiation (LASER) device assembly in which input energy is used to excite dimers (typically rare gas monohalides such as argon fluoride, xenon chloride) as the active medium to emit a beam of intense, coherent, monochromatic, electromagnetic (EM) radiation intended for the intraluminal photoablation or debulking of vascular lesion material (blockages, total occlusions) and sometimes to photoablate tissue attached to the leads of active implantable devices. It is intended to be used with an angioplasty catheter and typically consists of an electrical unit with a display, controls and/or foot-switch.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M204CVX300P0	HIBCC

Customer Contacts

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