HeartLight

Basic Information

• Brand Name: HeartLight
• Primary DI: 00859373007433
• Version / Model: 18-5000
• Catalog Number: 18-5000
• Company Name: CARDIOFOCUS, INC.
• Labeler DUNS: 068966261
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-05-19
• Public Version: 1
• Public Version Date: 2020-05-27
• Public Version Status: New
• Public Device Record Key: 79ed4207-a542-4916-98e4-2ad654fa9e49

Device Description

HeartLight X3 Disposable Motor Catheter

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: 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: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OAE	Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
61772	Cardiac ablation laser system beam guide-catheter	A sterile, flexible, steerable catheter intended to be used as part of a cardiac ablation laser system to invasively direct and deliver laser energy to the endocardium of a beating heart for the ablation of specific areas in the treatment of cardiac arrhythmias. It is intended to be introduced into the heart via venous access (e.g., femoral vein). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00859373007433	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P150026	008

Device Sizes

Type	Value	Unit	Text
Catheter Gauge	12	French