FARAPOINT™ M004PF81M310

GUDID 00191506047221

Pulsed Field Ablation Catheter

BOSTON SCIENTIFIC CORPORATION

Cardiac irreversible electroporation system catheter

• Primary Device ID: 00191506047221
• NIH Device Record Key: f37e765c-5f0b-45f3-a87c-0b9720daf0c0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FARAPOINT™
• Version Model Number: M004PF81M310
• Catalog Number: M004PF81M310
• Company DUNS: 021717889
• Company Name: BOSTON SCIENTIFIC CORPORATION
• 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: false
• Manufacturing Date: false
• 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

Device Dimensions

• Outer Diameter: 2.7 Millimeter
• Outer Diameter: 2.7 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00191506047221 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P230030

FDA Product Code

• QZI: Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-01-28
• Device Publish Date: 2026-01-20

On-Brand Devices [FARAPOINT™]

• 00191506047221: Pulsed Field Ablation Catheter
• 00191506047207: Pulsed Field Ablation Catheter