Mi-Axus Catheter

Basic Information

• Brand Name: Mi-Axus Catheter
• Primary DI: B293MIA9080S0
• Version / Model: MIA9080S
• Company Name: MIVI NEUROVASCULAR
• Labeler DUNS: 076836823
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-03-15
• Public Version: 7
• Public Version Date: 2021-12-22
• Public Version Status: Update
• Public Device Record Key: 9ba50084-8fec-43bd-8a8c-a9c44b8806ef

Device Description

The Mi-Axus 8F Guide Catheter is a single lumen, braided, variable stiffness shaft catheter designed for use in facilitating the insertion and guidance of micro catheters into a selected blood vessel in the peripheral, coronary, or neuro vascular system. A radiopaque marker is included on the distal end. The catheter shaft has a hydrophilic coating. The proximal segment is constructed with Vestamid. The distal segment of the PEBAX is impregnated with barium sulphate for increased radiopacity.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DQY	Catheter, Percutaneous	Cardiovascular	870.1250	2

GMDN Terms

Code	Name	Definition	Implantable	Status
17846	Vascular guide-catheter, single-use	A flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), needle or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section can have a variety of preformed shapes (e.g., straight, hockey stick). It is not intended solely for infusion, is not intended to access superselective small vessels, and does not include a transseptal needle. It may include a disposable percutaneous introduction set or shaft visualization electrodes. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B293MIA9080S0	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K151396	000

Device Sizes

Type	Value	Unit	Text
Length	80	Centimeter
Catheter Gauge	8	French

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Dark and dry