Microcatheters
Mi-Axus Catheter
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.
Mi-Axus Catheter models and sizes
From the FDA Global Unique Device Identification Database. Confirm with the manufacturer's instructions for use.
| Model / catalog no. | Size | MRI | Status |
|---|---|---|---|
| MIA9080 | Catheter Gauge 8 Fr; Length 80 cm | Not stated | Available |
| MIA9080S | Length 80 cm; Catheter Gauge 8 Fr | Not stated | Available |
| MIA9090 | Catheter Gauge 8 Fr; Length 90 cm | Not stated | Available |
| MIA9090S | Length 90 cm; Catheter Gauge 8 Fr | Not stated | Available |
| MIA9095S | Length 95 cm; Catheter Gauge 8 Fr | Not stated | Available |
FDA clearances
- 510(k) K151396 December 2015
Procedures that use microcatheters
Frequently asked questions
What is Mi-Axus Catheter used for?
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.
Who makes Mi-Axus Catheter?
Mi-Axus Catheter is made by Mivi Neurovascular. It is listed under microcatheters in our device library.
What sizes does Mi-Axus Catheter come in?
Sizes listed for Mi-Axus Catheter: Length: 80–95 cm; Catheter Gauge: 8 Fr. Confirm availability with the manufacturer's instructions for use.
Is Mi-Axus Catheter MRI safe?
The FDA device database entry for Mi-Axus Catheter does not state its MRI safety status. Check the labeling before MRI.
Is Mi-Axus Catheter FDA cleared?
Mi-Axus Catheter is covered by FDA submission K151396.
How do I contact a Mivi Neurovascular sales representative?
Mivi Neurovascular has not listed representatives on LA Vascular yet. Visit the Mivi Neurovascular company page for contact details.
Models, sizes and MRI status come from the FDA Global Unique Device Identification Database (GUDID); descriptions marked "provided by the manufacturer" are reviewed before publishing. Not an endorsement; follow the manufacturer's instructions for use.