Mi-Axus Catheter

GUDID B293MIA571120

The Mi-Axus 6F Distal Access Catheter is a single lumen, braided shaft, variable stiffness catheter with radiopaque marker on the distal end and a lue

MIVI NEUROVASCULAR

Vascular guide-catheter, single-use

• Primary Device ID: B293MIA571120
• NIH Device Record Key: 49ef7264-69b2-4114-a18a-1939dd80f683
• Commercial Distribution Discontinuation: 2019-02-08
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Mi-Axus Catheter
• Version Model Number: MIA-57112
• 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

• Catheter Gauge: 6 French
• Length: 112 Centimeter
• Catheter Gauge: 6 French
• Length: 112 Centimeter
• Catheter Gauge: 6 French
• Length: 112 Centimeter
• Catheter Gauge: 6 French
• Length: 112 Centimeter
• Catheter Gauge: 6 French
• Length: 112 Centimeter
• Catheter Gauge: 6 French
• Length: 112 Centimeter
• Catheter Gauge: 6 French
• Length: 112 Centimeter
• Catheter Gauge: 6 French
• Length: 112 Centimeter
• Catheter Gauge: 6 French
• Length: 112 Centimeter
• Catheter Gauge: 6 French
• Length: 112 Centimeter
• Catheter Gauge: 6 French
• Length: 112 Centimeter
• Catheter Gauge: 6 French
• Length: 112 Centimeter
• Catheter Gauge: 6 French
• Length: 112 Centimeter
• Catheter Gauge: 6 French
• Length: 112 Centimeter
• Catheter Gauge: 6 French
• Length: 112 Centimeter
• Catheter Gauge: 6 French
• Length: 112 Centimeter
• Catheter Gauge: 6 French
• Length: 112 Centimeter
• Catheter Gauge: 6 French
• Length: 112 Centimeter
• Catheter Gauge: 6 French
• Length: 112 Centimeter
• Catheter Gauge: 6 French
• Length: 112 Centimeter
• Catheter Gauge: 6 French
• Length: 112 Centimeter
• Catheter Gauge: 6 French
• Length: 112 Centimeter
• Catheter Gauge: 6 French
• Length: 112 Centimeter
• Catheter Gauge: 6 French
• Length: 112 Centimeter
• Catheter Gauge: 6 French
• Length: 112 Centimeter
• Catheter Gauge: 6 French
• Length: 112 Centimeter
• Catheter Gauge: 6 French
• Length: 112 Centimeter
• Catheter Gauge: 6 French
• Length: 112 Centimeter
• Catheter Gauge: 6 French
• Length: 112 Centimeter
• Catheter Gauge: 6 French
• Length: 112 Centimeter

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	B293MIA571120 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140557

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: 6
• Public Version Date: 2019-02-11
• Device Publish Date: 2016-09-19

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