Mi-Axus Catheter

GUDID B293MIA9080S0

The Mi-Axus 8F Guide Catheter is a single lumen, braided, variable stiffness shaft catheter designed for use in facilitating the insertion and guidanc

MIVI NEUROVASCULAR

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• Primary Device ID: B293MIA9080S0
• NIH Device Record Key: 9ba50084-8fec-43bd-8a8c-a9c44b8806ef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mi-Axus Catheter
• Version Model Number: MIA9080S
• Company DUNS: 076836823
• Company Name: MIVI NEUROVASCULAR
• 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

• Length: 80 Centimeter
• Catheter Gauge: 8 French
• Length: 80 Centimeter
• Catheter Gauge: 8 French
• Length: 80 Centimeter
• Catheter Gauge: 8 French
• Length: 80 Centimeter
• Catheter Gauge: 8 French
• Length: 80 Centimeter
• Catheter Gauge: 8 French
• Length: 80 Centimeter
• Catheter Gauge: 8 French
• Length: 80 Centimeter
• Catheter Gauge: 8 French
• Length: 80 Centimeter
• Catheter Gauge: 8 French
• Length: 80 Centimeter
• Catheter Gauge: 8 French
• Length: 80 Centimeter
• Catheter Gauge: 8 French
• Length: 80 Centimeter
• Catheter Gauge: 8 French
• Length: 80 Centimeter
• Catheter Gauge: 8 French
• Length: 80 Centimeter
• Catheter Gauge: 8 French
• Length: 80 Centimeter
• Catheter Gauge: 8 French
• Length: 80 Centimeter
• Catheter Gauge: 8 French
• Length: 80 Centimeter
• Catheter Gauge: 8 French
• Length: 80 Centimeter
• Catheter Gauge: 8 French
• Length: 80 Centimeter
• Catheter Gauge: 8 French
• Length: 80 Centimeter
• Catheter Gauge: 8 French
• Length: 80 Centimeter
• Catheter Gauge: 8 French
• Length: 80 Centimeter
• Catheter Gauge: 8 French
• Length: 80 Centimeter
• Catheter Gauge: 8 French
• Length: 80 Centimeter
• Catheter Gauge: 8 French
• Length: 80 Centimeter
• Catheter Gauge: 8 French
• Length: 80 Centimeter
• Catheter Gauge: 8 French
• Length: 80 Centimeter
• Catheter Gauge: 8 French
• Length: 80 Centimeter
• Catheter Gauge: 8 French
• Length: 80 Centimeter
• Catheter Gauge: 8 French
• Length: 80 Centimeter
• Catheter Gauge: 8 French
• Length: 80 Centimeter
• Catheter Gauge: 8 French

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Dark and dry
• Special Storage Condition, Specify: Between 0 and 0 *Dark and dry
• Special Storage Condition, Specify: Between 0 and 0 *Dark and dry
• Special Storage Condition, Specify: Between 0 and 0 *Dark and dry
• Special Storage Condition, Specify: Between 0 and 0 *Dark and dry
• Special Storage Condition, Specify: Between 0 and 0 *Dark and dry
• Special Storage Condition, Specify: Between 0 and 0 *Dark and dry
• Special Storage Condition, Specify: Between 0 and 0 *Dark and dry
• Special Storage Condition, Specify: Between 0 and 0 *Dark and dry
• Special Storage Condition, Specify: Between 0 and 0 *Dark and dry
• Special Storage Condition, Specify: Between 0 and 0 *Dark and dry
• Special Storage Condition, Specify: Between 0 and 0 *Dark and dry
• Special Storage Condition, Specify: Between 0 and 0 *Dark and dry
• Special Storage Condition, Specify: Between 0 and 0 *Dark and dry
• Special Storage Condition, Specify: Between 0 and 0 *Dark and dry
• Special Storage Condition, Specify: Between 0 and 0 *Dark and dry
• Special Storage Condition, Specify: Between 0 and 0 *Dark and dry
• Special Storage Condition, Specify: Between 0 and 0 *Dark and dry
• Special Storage Condition, Specify: Between 0 and 0 *Dark and dry
• Special Storage Condition, Specify: Between 0 and 0 *Dark and dry
• Special Storage Condition, Specify: Between 0 and 0 *Dark and dry
• Special Storage Condition, Specify: Between 0 and 0 *Dark and dry
• Special Storage Condition, Specify: Between 0 and 0 *Dark and dry
• Special Storage Condition, Specify: Between 0 and 0 *Dark and dry
• Special Storage Condition, Specify: Between 0 and 0 *Dark and dry
• Special Storage Condition, Specify: Between 0 and 0 *Dark and dry
• Special Storage Condition, Specify: Between 0 and 0 *Dark and dry
• Special Storage Condition, Specify: Between 0 and 0 *Dark and dry
• Special Storage Condition, Specify: Between 0 and 0 *Dark and dry
• Special Storage Condition, Specify: Between 0 and 0 *Dark and dry

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B293MIA9080S0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151396

FDA Product Code

• DQY: Catheter, Percutaneous

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-01-23
• Device Publish Date: 2017-03-15

On-Brand Devices [Mi-Axus Catheter]

• B293MIA9095S0: The Mi-Axus 8F Guide Catheter is a single lumen, braided, variable stiffness shaft catheter desi
• B293MIA9090S0: The Mi-Axus 8F Guide Catheter is a single lumen, braided, variable stiffness shaft catheter desi
• B293MIA90900: The Mi-Axus 8F Guide Catheter is a single lumen, braided, variable stiffness shaft catheter desi
• B293MIA9080S0: The Mi-Axus 8F Guide Catheter is a single lumen, braided, variable stiffness shaft catheter desi
• B293MIA90800: The Mi-Axus 8F Guide Catheter is a single lumen, braided, variable stiffness shaft catheter desi
• B293MIA571300: The Mi-Axus 6F Distal Access Catheter is a single lumen, braided shaft, variable stiffness cathe
• B293MIA571120: The Mi-Axus 6F Distal Access Catheter is a single lumen, braided shaft, variable stiffness cathe