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Mi-EXT Extension Catheter 6F 25cm, 5F 25cm, 4F 30cm, 3F 43cm

FDA 510(k)

Class II (US FDA 510(k))

510(k) K163233

by Mivi Neuroscience, Inc.

Identifiers

510(k) Number
K163233 FDA 510(k)
FDA Product Code
DQY FDA 510(k)

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 Mi-EXT Extension Catheter is a vascular extension catheter designed to facilitate the insertion and guidance of microcatheters within peripheral, coronary, and neurovascular systems. These catheters are engineered to provide a smooth, low-profile interface between guide catheters and microcatheters, enabling precise navigation through complex vascular pathways. Available in four sizes—6 French (F) 25 cm, 5F 25 cm, 4F 30 cm, and 3F 43 cm—they cater to varying procedural requirements in interventional radiology and cardiology.

The Mi-EXT Extension Catheter is supplied as a single-use, non-sterile device for professional medical use only. It is intended for use with compatible guide catheters and is classified under FDA product code DQY, with a clearance granted through the 510(k) pathway in April 2017. Storage and handling instructions must be followed to maintain device integrity, though specific sterility or MRI safety details are not provided in the regulatory data. The device is manufactured by Mivi Neuroscience, Inc., Eden Prairie, MN.

Frequently asked questions

What are the Mi-EXT Extension Catheters used for?

The Mi-EXT Extension Catheters are designed to facilitate the insertion and guidance of microcatheters within vascular systems, including peripheral, coronary, and neurovascular pathways. Their low-profile design reduces friction between guide catheters and microcatheters, enabling smoother and more precise navigation through complex blood vessels during interventional procedures.

Are these catheters sterile and single-use?

The Mi-EXT Extension Catheters are supplied as single-use devices but are not sterile at the time of shipment. They are intended for professional medical use only and must be handled according to the manufacturer’s storage and handling instructions to maintain device integrity before use.

What sizes are available for the Mi-EXT Extension Catheter?

Four sizes are available to accommodate different procedural needs: 6F (25 cm), 5F (25 cm), 4F (30 cm), and 3F (43 cm). The length and French size help clinicians select the appropriate catheter based on the patient’s anatomy and the specific vascular access requirements.

How should these catheters be stored?

While specific sterility or MRI safety details are not provided in the regulatory data, the manufacturer’s storage and handling instructions must be followed to preserve the device’s integrity. This typically includes protecting the catheter from contamination, moisture, and physical damage until use.

What regulatory pathway was used for FDA clearance?

The Mi-EXT Extension Catheter received FDA clearance through the 510(k) pathway in April 2017, with a determination of substantial equivalence to a predicate device. The clearance was granted under product code DQY (Vascular Grafts, Stents, and Catheters) and reviewed by the Cardiovascular (CV) Advisory Committee.

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: MIVI 6F 25cm Mi-EXT Extension Catheter, MIVI 5F 25cm Mi-EXT Extension ..., MIVI 6F 25cm Mi-EXT Extension Catheter MIVI 5F 25cm Mi-EXT Extension ..., mivi 6f 25cm mi-ext extension catheter mivi 5f 25cm mi-ext extension ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Mivi Neuroscience, Inc.

Sources (1)

  • FDA 510(k) K163233 24 fields · synced Oct 1, 2026