RoVo Mechanical Thrombectomy System VRG7513B3

GUDID M917VRG7513B30

RoVo Mechanical Thrombectomy System, Catheter

Verge Medical, Inc.

Thrombectomy suction catheter

• Primary Device ID: M917VRG7513B30
• NIH Device Record Key: 60260425-2531-4da1-a43e-ff2bad9a8964
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RoVo Mechanical Thrombectomy System
• Version Model Number: VRG7513B3
• Catalog Number: VRG7513B3
• Company DUNS: 078708447
• Company Name: Verge Medical, 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: 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

Customer Support Contacts

• Phone: 1-844-352-7411
• Email: customerservice@vergemedical.com
• Phone: 1-844-352-7411
• Email: customerservice@vergemedical.com
• Phone: 1-844-352-7411
• Email: customerservice@vergemedical.com

Device Dimensions

• Outer Diameter: 2 Millimeter
• Catheter Inner Diameter: 0.054 Inch
• Catheter Working Length: 100 Centimeter
• Outer Diameter: 2 Millimeter
• Catheter Inner Diameter: 0.054 Inch
• Catheter Working Length: 100 Centimeter
• Outer Diameter: 2 Millimeter
• Catheter Inner Diameter: 0.054 Inch
• Catheter Working Length: 100 Centimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store the packaged and sealed device in a dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the packaged and sealed device in a dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the packaged and sealed device in a dark, dry place.

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M917VRG7513B30 [Primary]
HIBCC	M917VRG7513B31 [Package]; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K253730

FDA Product Code

• QEW: Peripheral Mechanical Thrombectomy With Aspiration

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: 2026-02-16
• Device Publish Date: 2026-02-06

On-Brand Devices [RoVo Mechanical Thrombectomy System]

• M917VRG7513B30: RoVo Mechanical Thrombectomy System, Catheter
• M917RVHD1: RoVo Mechanical Thrombectomy System, Driver