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speX Support Catheter

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K173662

by Reflow Medical, Inc.

Identifiers

510(k) Number
K173662 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 speX Support Catheter is a shapeable microcatheter designed to provide reinforced vascular support. It is classified as a microcatheter, reinforced and is intended for use in crossing challenging peripheral lesions during interventional procedures.

This catheter is supplied as a single-use device and is compatible with various guide wires and procedural techniques. It maintains a customizable tip angle to enhance predictability in vascular access, with no specific sterility or MRI safety information provided in the data. Authorized under FDA 510(k) clearance (K173662) and MDR, it is intended for use in peripheral vascular applications as defined by its regulatory submission.

Frequently asked questions

What types of vascular procedures is the speX Support Catheter designed to assist with, and why is its shapeable design beneficial?

The speX Support Catheter is specifically designed to assist in crossing challenging peripheral lesions during interventional procedures, particularly in peripheral vascular applications. Its shapeable design allows for a customizable tip angle, which enhances predictability and precision when navigating complex or tortuous blood vessels. This flexibility helps clinicians achieve better control and stability during catheter placement, reducing the risk of misalignment or procedural complications.

Is the speX Support Catheter compatible with all guide wires, or are there specific types it works best with?

The speX Support Catheter is designed to be compatible with various guide wires and procedural techniques, though the exact compatibility details (such as wire diameters or materials) are not specified in the provided data. Clinicians should refer to the manufacturer’s instructions for specific guidance on optimal guide wire pairing to ensure safe and effective use during procedures.

How is the speX Support Catheter supplied, and is it intended for single-use only?

The speX Support Catheter is supplied as a single-use device, meaning it is intended for one-time use per patient procedure. This design choice aligns with best practices for infection control and sterility, ensuring each catheter remains uncontaminated and ready for immediate clinical use without reprocessing.

Are there different sizes or models of the speX Support Catheter, and if so, how might a clinician determine the appropriate one for a patient?

The provided data does not specify distinct sizes or models of the speX Support Catheter, such as shaft diameters or lengths. However, the catheter’s reinforced and shapeable design suggests it may offer variability in tip angles or flexibility to accommodate different vascular anatomies. Clinicians should consult the manufacturer’s documentation or technical support to select the most suitable catheter based on procedural requirements and patient-specific factors like vessel diameter or lesion complexity.

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: Spex Shapeable Support Microcatheter | US - Reflow Medical, Spex LP Shapeable Support Microcatheter | US | Reflow Medical, Spex Shapeable Support Microcatheter | OUS - Reflow Medical, Peripheral - Catheters - ReflowSPEX

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Reflow Medical, Inc.

Sources (2)

  • FDA 510(k) K173662 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced May 19, 2026