FARAWAVE™ M004PF41M431

GUDID 00191506043216

Pulsed Field Ablation Catheter

BOSTON SCIENTIFIC CORPORATION

Cardiac irreversible electroporation system catheter

• Primary Device ID: 00191506043216
• NIH Device Record Key: bdef459b-c1c3-4aa8-b1e8-c6d8943811c4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FARAWAVE™
• Version Model Number: M004PF41M431
• Catalog Number: M004PF41M431
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00191506043216 [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: 2024-10-30
• Device Publish Date: 2024-10-22

On-Brand Devices [FARAWAVE™]

• 00191506043155: Pulsed Field Ablation Catheter
• 00191506043148: Pulsed Field Ablation Catheter
• 00191506043223: Pulsed Field Ablation Catheter
• 00191506043216: Pulsed Field Ablation Catheter