LimFlow ARC

GUDID 00850041730011

The LimFlow ARC is a 6 Fr compatible catheter designed to facilitate placement and positioning of guide wires within the peripheral vasculature

Limflow Inc.

Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use

• Primary Device ID: 00850041730011
• NIH Device Record Key: 10a0e04e-4a7d-4438-8b3a-b435a3e28859
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LimFlow ARC
• Version Model Number: AC-US-21
• 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: true
• 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

Customer Support Contacts

• Phone: 18884787705
• Email: info@limflow.com
• Phone: 18884787705
• Email: info@limflow.com
• Phone: 18884787705
• Email: info@limflow.com
• Phone: 18884787705
• Email: info@limflow.com
• Phone: 18884787705
• Email: info@limflow.com
• Phone: 18884787705
• Email: info@limflow.com
• Phone: 18884787705
• Email: info@limflow.com
• Phone: 18884787705
• Email: info@limflow.com
• Phone: 18884787705
• Email: info@limflow.com
• Phone: 18884787705
• Email: info@limflow.com
• Phone: 18884787705
• Email: info@limflow.com
• Phone: 18884787705
• Email: info@limflow.com
• Phone: 18884787705
• Email: info@limflow.com
• Phone: 18884787705
• Email: info@limflow.com
• Phone: 18884787705
• Email: info@limflow.com
• Phone: 18884787705
• Email: info@limflow.com
• Phone: 18884787705
• Email: info@limflow.com
• Phone: 18884787705
• Email: info@limflow.com
• Phone: 18884787705
• Email: info@limflow.com
• Phone: 18884787705
• Email: info@limflow.com
• Phone: 18884787705
• Email: info@limflow.com
• Phone: 18884787705
• Email: info@limflow.com
• Phone: 18884787705
• Email: info@limflow.com
• Phone: 18884787705
• Email: info@limflow.com
• Phone: 18884787705
• Email: info@limflow.com
• Phone: 18884787705
• Email: info@limflow.com
• Phone: 18884787705
• Email: info@limflow.com
• Phone: 18884787705
• Email: info@limflow.com
• Phone: 18884787705
• Email: info@limflow.com
• Phone: 18884787705
• Email: info@limflow.com
• Phone: 18884787705
• Email: info@limflow.com
• Phone: 18884787705
• Email: info@limflow.com
• Phone: 18884787705
• Email: info@limflow.com
• Phone: 18884787705
• Email: info@limflow.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850041730011 [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: 2023-07-04
• Device Publish Date: 2023-06-26

Devices Manufactured by Limflow Inc.

• 00850041730134 - LimFlow Vector: 2024-04-22 The LimFlow Vector is intended for the treatment of vascular disorders and more particularly for excising or disrupting venous v
• 00850041730141 - LimFlow V-Ceiver: 2024-03-18 The LimFlow V-Ceiver is intended for use in the cardiovascular system to manipulate and retrieve guidewires specified in the IFU
• 00850041730035 - LimFlow System: 2023-10-10 LimFlow Extension Stent Graft (5.5 mm x 200 mm) with the Handle Delivery System. The LimFlow System is indicated for patients wh
• 00850041730042 - LimFlow System: 2023-10-10 LimFlow Extension Stent Graft (5.5 mm x 150 mm) with the Handle Delivery System. The LimFlow System is indicated for patients wh
• 00850041730059 - LimFlow System: 2023-10-10 LimFlow Extension Stent Graft (5.5 mm x 100 mm) with the Handle Delivery System. The LimFlow System is indicated for patients wh
• 00850041730073 - LimFlow System: 2023-10-10 LimFlow Extension stent graft (5.5 mm x 60 mm) with the Handle Delivery System. The LimFlow System is indicated for patients who
• 00850041730097 - LimFlow System: 2023-10-10 LimFlow Conical Stent Graft (3.5-5.5 mm x 60 mm) with the Handle Delivery System. The LimFlow System is indicated for patients w
• 00850041730110 - LimFlow System: 2023-10-10 LimFlow Conical Stent Graft (4.0-5.5 mm x 60 mm) with the Handle Delivery System. The LimFlow System is indicated for patients w