Identifiers
- 510(k) Number
- K151880 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 Crossing Catheter is a microcatheter designed for percutaneous coronary and peripheral vascular interventions, specifically for crossing chronic total occlusions (CTOs) in peripheral artery disease. Its braid-reinforced hypotube construction provides enhanced pushability and torque control, while the extendable beveled tip facilitates precise lesion traversal. The device is engineered to support rapid, on-the-fly lesion crossing with improved maneuverability in complex anatomical challenges. Its hydrophilic coating ensures smooth advancement through calcified or tortuous vessels, reducing procedural friction and enhancing safety.
The Wingman Crossing Catheter is supplied as a single-use device, intended for use in interventional radiology and cardiology settings. It is not MRI-safe and must be handled with sterile technique, requiring aseptic preparation before use. The device is available in specific model variants, including the P/N 100986 revision, and is regulated under FDA 510(k) clearance (K151880) as a substantially equivalent device to predecessors. Storage should follow manufacturer guidelines to maintain sterility and functionality, and any device failure during use must be reported to the manufacturer as per regulatory requirements.
Frequently asked questions
What is the Wingman Crossing Catheter designed for?
The Wingman Crossing Catheter is specifically engineered for percutaneous coronary and peripheral vascular interventions, particularly to cross chronic total occlusions (CTOs) in peripheral artery disease. Its braid-reinforced hypotube construction enhances pushability and torque control, while the extendable beveled tip allows for precise lesion traversal. This design supports rapid, on-the-fly crossing of complex blockages in tortuous or calcified vessels.
How is the Wingman Crossing Catheter supplied and intended for use?
The Wingman Crossing Catheter is supplied as a single-use device, intended exclusively for interventional radiology and cardiology procedures. It requires aseptic preparation before use due to its sterile packaging, ensuring patient safety during vascular interventions. The device is not designed for reuse or MRI compatibility.
What model variants are available for the Wingman Crossing Catheter?
The Wingman Crossing Catheter is available in specific model variants, including the P/N 100986 revision. These variants may differ in technical specifications or features to accommodate varying clinical needs, such as vessel diameter or lesion complexity. For exact specifications, refer to the manufacturer’s documentation.
How should the Wingman Crossing Catheter be stored?
Storage of the Wingman Crossing Catheter must follow the manufacturer’s guidelines to preserve sterility and functionality. Proper storage conditions typically include protection from moisture, extreme temperatures, and physical damage. Always check the packaging instructions for detailed storage recommendations to ensure optimal performance during use.
What should be done if the device fails during use?
If the Wingman Crossing Catheter fails or malfunctions during use, the procedure should be paused immediately for patient safety. Any device failure must be reported to the manufacturer, Reflow Medical, Inc., as per regulatory requirements. This ensures proper investigation and helps maintain device performance and patient safety standards.
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, Peripheral - Catheters - ReflowWINGMAN
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K151880 | Class II | Active |
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Manufacturer
- Manufacturer
- Reflow Medical, Inc.
- FDA Applicant
- Reflow Medical
Sources (1)
- FDA 510(k) K151880 24 fields · synced Oct 5, 2026