đź“‹ FDA Reference
Asahi Corsair Armet 18 Microcatheter Model Csar060-18n Asahi Corsair Armet 18 Microcatheter Model Csar090-18n Asahi Corsair Armet 18 Microcatheter Model Csar110-18n Asahi Corsair Armet 18 Microcatheter Model Csar135-18n
Product: ASAHI Corsair Armet 18 — all models and sizes
Summary: The Asahi Corsair Armet 18 Microcatheter is a specialized catheter used in vascular procedures, primarily by interventional radiologists and cardiologists. It is designed for navigating complex vascular pathways.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K202252 ↗
Decision Date ?
September 8, 2020
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The Asahi Corsair Armet 18 Microcatheter was cleared via the FDA 510(k) pathway on September 8, 2020. Manufactured by Asahi Intecc, it is classified as a Class 2 device under the product code DQY.
What It Is
The Asahi Corsair Armet 18 Microcatheter is a flexible, small-diameter catheter designed to navigate through the intricate and narrow pathways of the vascular system. It is used to facilitate the delivery of therapeutic agents or other devices to specific sites within the vasculature. Its design allows for enhanced maneuverability and access in challenging anatomical regions.
FDA-Cleared Indications
- For percutaneous vascular procedures that require catheter navigation through the vasculature.
- For delivery of therapeutic agents or other compatible interventional devices to a selected vascular location.
- For use in the peripheral and coronary vasculature when a small-diameter catheter is clinically appropriate.
Clinical Applications
- Catheter-based navigation through small or tortuous peripheral blood vessels.
- Delivery of compatible guidewires, therapeutic agents, or other devices to a selected vascular site.
- Support of percutaneous vascular interventions requiring selective vessel access.
- Use during selected coronary or peripheral vascular procedures when the device specifications and anatomy are appropriate.
Practical Considerations
- Models include CSAR060-18N, CSAR090-18N, CSAR110-18N, and CSAR135-18N, representing different catheter lengths.
- The catheter is used with compatible guidewires and other devices according to the manufacturer's specifications.
- Selection depends on the target vessel, access route, anatomy, required reach, and the size and compatibility of the intended guidewire or treatment device.
- It is a single-use catheter; it is not intended to remain permanently implanted and should not be reused or resterilized.
- MRI conditions and safety depend on the current manufacturer labeling. The device should be assessed using its official instructions for use before MRI, and it should not be assumed to be universally MRI safe.
Procedures that use this device
Frequently Asked Questions
What is the Asahi Corsair Armet 18 Microcatheter used for?
It is used for navigating and accessing complex vascular pathways to deliver therapeutic agents or devices.
What specialties typically use this device?
Interventional radiologists and cardiologists typically use this device in vascular procedures.
What are the FDA-cleared indications?
The device is indicated for use in vascular procedures requiring precise navigation and delivery in small or tortuous vessels.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.