LimFlow ARC

GUDID 00850041730158

The LimFlow ARC is intended to facilitate placement and positioning of guidewires and catheters within the peripheral vasculature. The LimFlow ARC is not intended for use in the coronary or cerebral vasculature

Limflow Inc.

Vascular guide-catheter, single-use

• Primary Device ID: 00850041730158
• NIH Device Record Key: 2d5c48ab-c7cf-411c-b32b-f07e34164f25
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LimFlow ARC
• Version Model Number: AC-US-23
• Company DUNS: 096651686
• Company Name: Limflow 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850041730158 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221541

FDA Product Code

• PDU: Catheter For Crossing Total Occlusions

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: 2024-04-29
• Device Publish Date: 2024-04-19

On-Brand Devices [LimFlow ARC]

• 00850041730011: The LimFlow ARC is a 6 Fr compatible catheter designed to facilitate placement and positioning o
• 00850041730158: The LimFlow ARC is intended to facilitate placement and positioning of guidewires and catheters