Mi-EXT Distal Access Catheter

GUDID B293MIEXT36370

The MIVI Mi-EXT™ Catheter is a single-lumen, variable stiffness catheter with radiopaque markers on the distal and proximal end of the catheter portio

MIVI NEUROVASCULAR

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• Primary Device ID: B293MIEXT36370
• NIH Device Record Key: 9439362f-ca29-438c-a4aa-4f1e863d510e
• Commercial Distribution Discontinuation: 2018-12-07
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Mi-EXT Distal Access Catheter
• Version Model Number: Mi-EXT-3637
• 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: 154 Centimeter
• Catheter Gauge: 3 French
• Length: 154 Centimeter
• Catheter Gauge: 3 French
• Length: 154 Centimeter
• Catheter Gauge: 3 French
• Length: 154 Centimeter
• Catheter Gauge: 3 French
• Length: 154 Centimeter
• Catheter Gauge: 3 French
• Length: 154 Centimeter
• Catheter Gauge: 3 French
• Length: 154 Centimeter
• Catheter Gauge: 3 French
• Length: 154 Centimeter
• Catheter Gauge: 3 French
• Length: 154 Centimeter
• Catheter Gauge: 3 French
• Length: 154 Centimeter
• Catheter Gauge: 3 French
• Length: 154 Centimeter
• Catheter Gauge: 3 French
• Length: 154 Centimeter
• Catheter Gauge: 3 French
• Length: 154 Centimeter
• Catheter Gauge: 3 French
• Length: 154 Centimeter
• Catheter Gauge: 3 French
• Length: 154 Centimeter
• Catheter Gauge: 3 French
• Length: 154 Centimeter
• Catheter Gauge: 3 French
• Length: 154 Centimeter
• Catheter Gauge: 3 French
• Length: 154 Centimeter
• Catheter Gauge: 3 French
• Length: 154 Centimeter
• Catheter Gauge: 3 French
• Length: 154 Centimeter
• Catheter Gauge: 3 French
• Length: 154 Centimeter
• Catheter Gauge: 3 French
• Length: 154 Centimeter
• Catheter Gauge: 3 French
• Length: 154 Centimeter
• Catheter Gauge: 3 French
• Length: 154 Centimeter
• Catheter Gauge: 3 French
• Length: 154 Centimeter
• Catheter Gauge: 3 French
• Length: 154 Centimeter
• Catheter Gauge: 3 French
• Length: 154 Centimeter
• Catheter Gauge: 3 French
• Length: 154 Centimeter
• Catheter Gauge: 3 French
• Length: 154 Centimeter
• Catheter Gauge: 3 French
• Length: 154 Centimeter
• Catheter Gauge: 3 French

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Dry and dark
• Special Storage Condition, Specify: Between 0 and 0 *Dry and dark
• Special Storage Condition, Specify: Between 0 and 0 *Dry and dark
• Special Storage Condition, Specify: Between 0 and 0 *Dry and dark
• Special Storage Condition, Specify: Between 0 and 0 *Dry and dark
• Special Storage Condition, Specify: Between 0 and 0 *Dry and dark
• Special Storage Condition, Specify: Between 0 and 0 *Dry and dark
• Special Storage Condition, Specify: Between 0 and 0 *Dry and dark
• Special Storage Condition, Specify: Between 0 and 0 *Dry and dark
• Special Storage Condition, Specify: Between 0 and 0 *Dry and dark
• Special Storage Condition, Specify: Between 0 and 0 *Dry and dark
• Special Storage Condition, Specify: Between 0 and 0 *Dry and dark
• Special Storage Condition, Specify: Between 0 and 0 *Dry and dark
• Special Storage Condition, Specify: Between 0 and 0 *Dry and dark
• Special Storage Condition, Specify: Between 0 and 0 *Dry and dark
• Special Storage Condition, Specify: Between 0 and 0 *Dry and dark
• Special Storage Condition, Specify: Between 0 and 0 *Dry and dark
• Special Storage Condition, Specify: Between 0 and 0 *Dry and dark
• Special Storage Condition, Specify: Between 0 and 0 *Dry and dark
• Special Storage Condition, Specify: Between 0 and 0 *Dry and dark
• Special Storage Condition, Specify: Between 0 and 0 *Dry and dark
• Special Storage Condition, Specify: Between 0 and 0 *Dry and dark
• Special Storage Condition, Specify: Between 0 and 0 *Dry and dark
• Special Storage Condition, Specify: Between 0 and 0 *Dry and dark
• Special Storage Condition, Specify: Between 0 and 0 *Dry and dark
• Special Storage Condition, Specify: Between 0 and 0 *Dry and dark
• Special Storage Condition, Specify: Between 0 and 0 *Dry and dark
• Special Storage Condition, Specify: Between 0 and 0 *Dry and dark
• Special Storage Condition, Specify: Between 0 and 0 *Dry and dark
• Special Storage Condition, Specify: Between 0 and 0 *Dry and dark

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B293MIEXT36370 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163233

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: 2017-06-01

On-Brand Devices [Mi-EXT Distal Access Catheter]

• B293MIEXT6925U0: The MIVI Mi-EXT™ Catheter is a single-lumen, variable stiffness catheter with radiopaque marke
• B293MIEXT69250: The MIVI Mi-EXT™ Catheter is a single-lumen, variable stiffness catheter with radiopaque marke
• B293MIEXT57250: The MIVI Mi-EXT™ Catheter is a single-lumen, variable stiffness catheter with radiopaque marke
• B293MIEXT43300: The MIVI Mi-EXT™ Catheter is a single-lumen, variable stiffness catheter with radiopaque marke
• B293MIEXT36370: The MIVI Mi-EXT™ Catheter is a single-lumen, variable stiffness catheter with radiopaque marke