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Wingman Extendable Tip Support Catheter

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K132420

by Reflow Medical, Inc.

Identifiers

510(k) Number
K132420 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 Extendable Tip Support Catheter is a support catheter designed for recanalization procedures, specifically to assist in crossing chronic total occlusions (CTOs) in peripheral arteries. Its beveled tip and braid-reinforced hypotube provide enhanced support to steerable guidewires, facilitating lesion traversal in complex vascular regions. The device is categorized under peripheral vascular intervention tools, optimized for precision and stability during interventional radiology or cardiology procedures.

This catheter is supplied as a single-use device, featuring a hydrophilic coating for improved maneuverability and control. It is intended for use in MRI-unsafe environments due to its metallic components. The device is available in specific configurations as detailed in the IFU, with regulatory clearance under FDA 510K (K132420) and MDR compliance. Storage requires adherence to sterile packaging conditions to maintain integrity prior to use.

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, Wingman CTO Crossing Catheter | JP | Reflow Medical, PDF English Wingman CTO Crossing Catheter IFU P/N 100986 Rev. A Date 2024-08

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Reflow Medical, Inc.
FDA Applicant
Reflow Medical

Sources (2)

  • FDA 510(k) K132420 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced Jun 1, 2026