Microcatheters
NavienTM
A sterile, small-diameter, single-lumen, flexible tube designed for the controlled infusion of fluids (e.g., thrombolytics, diagnostic contrast media) into superselective small vessels (including intracranial, peripheral, or occluded coronary vasculature) for angiography/treatment, and typically also for the delivery of devices (e.g., embolization implants, guidewires) into tortuous vessels or across tight lesions. It may include an ultrasound transducer, a thermal sensor, and a hole for guidewire placement located at the distal tip. It is not a guide-catheter (i.e., is not intended to deliver other catheters or therapeutic leads directly through its lumen). This is a single-use device.
NavienTM 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 |
|---|---|---|---|
| RFX058-105-08 | — | Not stated | Available |
| RFX058-115-08 | — | Not stated | Available |
| RFX072-95-08 | — | Not stated | Available |
| RFX072-95-08MP | — | Not stated | Available |
| RFX072-130-08 | — | Not stated | Available |
| RFX072-130-08MP | — | Not stated | Available |
FDA clearances
- 510(k) K110055 April 2011
Procedures that use microcatheters
Frequently asked questions
What is NavienTM used for?
A sterile, small-diameter, single-lumen, flexible tube designed for the controlled infusion of fluids (e.g., thrombolytics, diagnostic contrast media) into superselective small vessels (including intracranial, peripheral, or occluded coronary vasculature) for angiography/treatment, and typically also for the delivery of devices (e.g., embolization implants, guidewires) into tortuous vessels or across tight lesions. It may include an ultrasound transducer, a thermal sensor, and a hole for guidewire placement located at the distal tip. It is not a guide-catheter (i.e., is not intended to deliver other catheters or therapeutic leads directly through its lumen). This is a single-use device.
Who makes NavienTM?
NavienTM is made by Micro Therapeutics, Inc.. It is listed under microcatheters in our device library.
What sizes does NavienTM come in?
The FDA device database does not list sizes for NavienTM. Check the instructions for use or ask a Micro Therapeutics, Inc. representative.
Is NavienTM MRI safe?
The FDA device database entry for NavienTM does not state its MRI safety status. Check the labeling before MRI.
Is NavienTM FDA cleared?
NavienTM is covered by FDA submission K110055.
How do I contact a Micro Therapeutics, Inc. sales representative?
Micro Therapeutics, Inc. has not listed representatives on LA Vascular yet. Visit the Micro Therapeutics, Inc. 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.