SmartClaw™ FD0660-02

GUDID 00191506050023

Thrombectomy Catheter

Devoro Medical Inc.

Thrombectomy suction catheter

• Primary Device ID: 00191506050023
• NIH Device Record Key: 9cf91737-ba7a-44b2-a4ad-26890f8d5ff9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SmartClaw™
• Version Model Number: FD0660-02
• Catalog Number: FD0660-02
• Company DUNS: 117672411
• Company Name: Devoro 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

Device Dimensions

• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00191506050023 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241207

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: 2024-06-13
• Device Publish Date: 2024-06-05

On-Brand Devices [SmartClaw™]

• 00191506050023: Thrombectomy Catheter
• 00191506050016: Thrombectomy Catheter