Wingman Extendable Tip Support Catheter
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K101479 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 to facilitate guidewire navigation through complex or occluded vascular lesions. Its extendable tip provides enhanced maneuverability, allowing operators to cross challenging anatomy by extending, rotating, and retracting the tip under control of an integrated handle. This device is intended for use in percutaneous coronary interventions (PCI) where standard guidewires encounter difficulty advancing through tight or calcified segments. The catheter’s design aims to improve procedural success in high-risk lesion crossings by offering mechanical support and flexibility.
The device is supplied as a single-use, non-sterile catheter requiring terminal sterilization prior to use. It is intended for use in electrocardiogram (ECG)-monitored cardiac catheterization labs under fluoroscopic guidance. The catheter is compatible with standard guidewires and is available in sizes and configurations specified in the manufacturer’s instructions. FDA clearance under 510(k) number K101479 confirms its regulatory status as a Class II device, with no specific MRI safety labeling indicated. Sterility and handling instructions must be followed as per the manufacturer’s documentation.
Frequently asked questions
What is the Wingman Extendable Tip Support Catheter used for?
This catheter is designed to assist in percutaneous coronary interventions (PCI) by helping guidewires navigate through difficult or occluded vascular segments, such as tight or calcified lesions. Its extendable tip provides enhanced maneuverability, allowing operators to extend, rotate, and retract the tip under precise control via an integrated handle. This improves procedural success in high-risk cases where standard guidewires struggle to advance.
How is the Wingman Extendable Tip Support Catheter supplied and prepared for use?
The catheter is supplied as a single-use, non-sterile device. Terminal sterilization must be performed prior to use, following the manufacturer’s guidelines. It is intended for use in ECG-monitored cardiac catheterization labs under fluoroscopic guidance, ensuring proper visualization during procedures.
Is the Wingman Extendable Tip Support Catheter reusable?
No, the Wingman Extendable Tip Support Catheter is explicitly designed for single-use only. Reuse is not recommended or supported by the manufacturer, as it could compromise sterility, functionality, or patient safety. Always follow the manufacturer’s instructions for proper disposal after a single procedure.
What sizes and configurations are available for the Wingman Extendable Tip Support Catheter?
The available sizes and configurations are specified in the manufacturer’s instructions for use. These details outline compatibility with standard guidewires and the specific dimensions required for different clinical scenarios. For precise sizing information, refer to the accompanying documentation provided by Reflow Medical.
How should the Wingman Extendable Tip Support Catheter be stored?
Storage instructions are provided in the manufacturer’s documentation to maintain the catheter’s integrity and sterility before terminal sterilization. Proper storage conditions, such as temperature and humidity control, are critical to preserving the device’s performance. Always adhere to the guidelines to ensure the catheter remains functional and safe for 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: PDF W INGMAN - reflowmedical.com, Wingman Extendable Tip Support Catheter - Reflow Medical | FDA Reference, PDF INGMAN - Reflow Medical
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K101479 | Class II | Active |
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Manufacturer
- Manufacturer
- Reflow Medical, Inc.
- FDA Applicant
- Reflow Medical
Sources (1)
- FDA 510(k) K101479 24 fields · synced Oct 6, 2026