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Wingman 18 Crossing Catheter

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K160848

by Reflow Medical, Inc.

Identifiers

510(k) Number
K160848 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 Wingman 18 Crossing Catheter is a braid-reinforced microcatheter designed for percutaneous vascular access, classified under the nomenclature for catheters, vascular, peripheral. It is engineered to facilitate the crossing of complex lesions, including chronic total occlusions (CTOs), in peripheral artery disease by providing enhanced pushability and torque control through its reinforced hypotube structure and extendable beveled tip.

This catheter is supplied as a single-use, non-sterile device, intended for use in interventional radiology and cardiology settings. It features a Control Point™ activation and engagement handle and a Control Coat™ hydrophilic coating to improve maneuverability and reduce friction. The device is MRI-unsafe and must be stored in a dry environment at room temperature. Authorized under FDA 510K clearance (K160848) and MDR compliance, it adheres to regulatory standards for vascular catheters.

Frequently asked questions

What is the Wingman 18 Crossing Catheter primarily designed to assist with in vascular procedures?

The Wingman 18 Crossing Catheter is specifically engineered to help navigate and cross complex vascular lesions, such as chronic total occlusions (CTOs), in patients with peripheral artery disease. Its braid-reinforced hypotube structure and extendable beveled tip improve pushability and torque control, making it easier to maneuver through challenging areas during interventional radiology or cardiology procedures.

Is the Wingman 18 Crossing Catheter intended for reuse, or is it meant to be used only once?

The Wingman 18 Crossing Catheter is supplied as a single-use device, meaning it is designed for one-time use only. This aligns with standard practices for microcatheters to ensure patient safety and sterility.

How should the Wingman 18 Crossing Catheter be stored, and what environmental conditions are required?

The device must be stored in a dry environment at room temperature. It is supplied as a non-sterile product, so it should not be exposed to moisture or extreme temperatures before use.

What special features does the Wingman 18 Crossing Catheter include to improve usability during procedures?

The catheter includes a Control Point™ activation and engagement handle for better maneuverability, as well as a Control Coat™ hydrophilic coating to reduce friction and enhance smooth navigation through vessels. These features help improve pushability and torque control during complex interventions.

Is the Wingman 18 Crossing Catheter compatible with MRI imaging, or does it pose any safety concerns in an MRI environment?

The Wingman 18 Crossing Catheter is MRI-unsafe, meaning it should not be used in or near an MRI scanner. The presence of metallic components or reinforced structures in the device could pose risks during MRI procedures, including potential heating or imaging artifacts.

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: Peripheral - Catheters - ReflowWINGMAN, PDF English 1 Wingman CTO Crossing Catheter P/N 100986 Rev. D 2025-06, Wingman CTO Crossing Catheter | JP | Reflow Medical, Reflow Medical Wingman | Peripheral CTO Crossing Catheter

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) K160848 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced May 18, 2026