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ASAHI Veloute +3 more models

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K241158

by Asahi Intecc Co., Ltd.

Identifiers

510(k) Number
K241158 FDA 510(k)
FDA Product Code
DQY FDA 510(k)
Models / Variants
ASAHI Veloute FDA 510(k)EUDAMED
ASAHI Veloute C3 FDA 510(k)EUDAMED
ASAHI Tellus FDA 510(k)EUDAMED
ASAHI Tellus C3 FDA 510(k)EUDAMED

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.1250 FDA 510(k)
Regulation Number
870.1250 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Asahi Veloute and Asahi Tellus are microcatheters designed for ultra-selective embolization procedures in interventional radiology. These devices feature a braided wire construction to optimize flexibility and pushability, enabling precise navigation through complex vascular pathways. Their tip design enhances guidewire tracking and stability during embolic material delivery, reducing the risk of catheter kickback.

Supplied as single-use devices, the Asahi Veloute and Asahi Tellus are intended for use in MRI-unsafe environments. They are available in multiple configurations (C3 variants included) and must be stored under sterile conditions as per manufacturer guidelines. Authorized under FDA 510K and MDR, these catheters are classified under product code DQY for cardiovascular applications, adhering to regulatory standards for interventional radiology tools.

Frequently asked questions

What types of vascular procedures are these microcatheters designed to support, and why is their braided wire construction important?

The ASAHI Veloute and ASAHI Tellus microcatheters are specifically designed for ultra-selective embolization procedures in interventional radiology. Their braided wire construction enhances flexibility and pushability, allowing precise navigation through tortuous or complex blood vessels. This design also improves guidewire tracking and tip stability, which reduces the risk of catheter kickback during embolic material delivery—critical for accurate and controlled interventions.

Are these catheters reusable, or do they need to be discarded after a single use? How does this affect their clinical workflow?

The ASAHI Veloute and ASAHI Tellus catheters are single-use devices, meaning they must be discarded after one procedure. This design choice ensures sterility and reduces the risk of cross-contamination between patients. Clinically, this simplifies workflow by eliminating the need for reprocessing, though it requires careful inventory management to maintain availability for multiple cases.

Can these catheters be used in MRI environments, and if not, what precautions should be taken during procedures?

No, these catheters are not MRI-safe and are explicitly intended for use in MRI-unsafe environments. If MRI imaging is required before or after the procedure, the catheter must be removed, and alternative imaging modalities (e.g., fluoroscopy) should be used. Clinicians should confirm the absence of MRI-compatible components in the procedure room and follow institutional protocols for managing non-MRI-safe devices.

What storage conditions are required to maintain sterility for these catheters, and how should they be handled before use?

The catheters must be stored under sterile conditions as specified by the manufacturer. They should remain in their original packaging until immediately before use, protected from contamination. Once opened, they should be handled with sterile gloves and used promptly to avoid compromising sterility. Proper storage ensures reliability and safety during sensitive embolization procedures.

What distinguishes the C3 variants (e.g., ASAHI Veloute C3) from the standard models, and how might this affect procedure selection?

The C3 variants (e.g., ASAHI Veloute C3) are part of the multiple configurations available for these catheters, though the exact differences in specifications (e.g., tip shape, length, or lumen diameter) are not detailed in the provided data. Typically, such variants may offer enhanced maneuverability or compatibility with specific embolic materials or vascular anatomies. Clinicians should consult the manufacturer’s documentation to determine which variant best suits their procedural needs, such as navigating particularly complex vessels or delivering specific embolic agents.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: ASAHI Veloute | Asahi Intecc Medical, ASAHI Veloute | Medical products for Interventional Radiology | ASAHI ..., ASAHI Tellus | Asahi Intecc Medical

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Asahi Intecc Co., Ltd.

Sources (2)

  • FDA 510(k) K241158 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 18, 2026