HeartLight 18-2531-N250

GUDID 00868976000109

Laser Ablation Balloon Catheter

CARDIOFOCUS, INC.

Cardiac ablation laser system beam guide-catheter

• Primary Device ID: 00868976000109
• NIH Device Record Key: a576b3aa-5bb0-4bcf-9eba-38eff4b3679a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HeartLight
• Version Model Number: 18-2531-N250
• Catalog Number: 18-2531-N250
• Company DUNS: 068966261
• Company Name: CARDIOFOCUS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(844)527-3723
• Email: customerservice@cardiofocus.com

Device Dimensions

• Catheter Gauge: 12 French
• Catheter Gauge: 12 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	00868976000109 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P150026

FDA Product Code

• OAE: Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[00868976000109]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-06-15

On-Brand Devices [HeartLight]

• 00868976000178: Endoscopic Ablation Catheter
• 00868976000161: Endoscopic Ablation Console (JP)
• 00868976000154: Laser Ablation Console
• 00868976000147: Deflectable Sheath
• 00868976000130: Balloon Fill Media
• 00868976000123: Endoscope
• 00868976000116: Endoscopic Ablation Console (EU)
• 00868976000109: Laser Ablation Balloon Catheter