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SeQure NF and SeQure Microcatheters

FDA 510(k)

Class II (US FDA 510(k))

510(k) K173430

by Accurate Medical Therapeutics, Ltd.

Identifiers

510(k) Number
K173430 FDA 510(k)
FDA Product Code
DQO FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.1200 FDA 510(k)
Regulation Number
870.1200 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The SeQure NF and SeQure Microcatheters are medical devices used for the infusion of contrast media into peripheral vessels and for drug infusion in intra-arterial therapy, as well as the infusion of embolic materials. They are designed for use by interventional radiologists and interventional oncologists.

The SeQure NF and SeQure Microcatheters are supplied as Class IIb medical devices and have been found to be substantially equivalent. They have been authorized under FDA 510K clearance and are associated with the product code DQO.

Frequently asked questions

What are the SeQure® NF and Microcatheters primarily used for?

These catheters are designed for infusion of contrast media into peripheral vessels, drug delivery during intra-arterial therapy, and the administration of embolic materials. Their specialized design supports precise targeting in interventional radiology and oncology procedures, ensuring accurate medication or material placement while minimizing trauma to surrounding tissues.

How are the SeQure® NF and Microcatheters supplied, and what does this imply for clinical use?

The SeQure® NF and Microcatheters are supplied as Class IIb medical devices, which indicates they undergo rigorous regulatory review to ensure safety and performance. This classification also implies they are intended for single-use, as multi-use devices typically fall into lower risk categories. Clinicians should follow manufacturer guidelines for sterile handling and disposal to maintain sterility and prevent cross-contamination.

Are these catheters reusable, or are they intended for single-use only?

The SeQure® NF and Microcatheters are intended for single-use only. Single-use devices are designed to minimize infection risks and ensure consistent performance per procedure. Reusing medical devices can compromise sterility, increase the risk of contamination, and may violate regulatory standards for device safety and efficacy.

What regulatory pathway was followed for FDA clearance of these catheters?

The SeQure® NF and Microcatheters were authorized under the FDA’s 510(k) clearance process, specifically through a Traditional review pathway. This means their safety and performance were compared to a legally marketed predicate device (a previously approved catheter) to demonstrate substantial equivalence. The clearance was granted by the Cardiovascular (CV) Advisory Committee, ensuring the device meets established standards for infusion catheters in vascular procedures.

What distinguishes the SeQure® NF model from the SeQure® Microcatheters?

While the exact distinguishing features between the SeQure® NF and SeQure® Microcatheters are not detailed in the provided data, the naming convention suggests differences in size or intended application. Typically, 'NF' may refer to a larger or more robust catheter designed for specific vascular access challenges, whereas 'Microcatheters' likely indicate smaller, more precise tools for delicate or microvascular procedures. For precise clinical selection, refer to the manufacturer’s technical specifications or consult interventional guidelines.

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: SeQure® | Interventional Radiology, Argon Medical Acquires SeQure® and DraKon™ Microcatheters, PDF Guerbet divests assets of its Accurate Medical microcatheter activity ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Accurate Medical Therapeutics, Ltd.

Sources (1)

  • FDA 510(k) K173430 24 fields · synced Oct 1, 2026