Wingman 14, Wingman 14C, Wingman 18, Wingman 35
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K193596 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 14, Wingman 14C, Wingman 18, and Wingman 35 are steerable peripheral crossing catheters designed for vascular access. These devices are intended to facilitate navigation through discrete regions of the peripheral vasculature, enabling precise placement and exchange of guidewires and interventional tools. Their flexible construction supports the delivery of diagnostic and therapeutic devices beyond challenging anatomical segments.
Supplied as single-use devices, the Wingman catheters are intended for use in interventional radiology and cardiology settings. Each model (14, 14C, 18, and 35) is approved under FDA 510(k) clearance (K193596) and classified under product code DQY. They are not MRI-compatible and must be stored in a clean, dry environment prior to use, adhering to standard sterile barrier packaging protocols.
Frequently asked questions
What is the Wingman 14C catheter designed for?
The Wingman 14C is a steerable peripheral crossing catheter intended to assist clinicians in navigating through difficult sections of the peripheral vasculature. Its flexible design allows for precise placement of guidewires and interventional tools, facilitating both diagnostic and therapeutic procedures in interventional radiology and cardiology settings.
Are the Wingman catheters reusable or single-use?
The Wingman catheters (14, 14C, 18, and 35) are supplied as single-use devices. This design ensures sterility and reduces the risk of cross-contamination between patients, adhering to best practices for medical device usage in clinical environments.
How should Wingman catheters be stored before use?
Wingman catheters must be stored in a clean, dry environment prior to use. They come in sterile barrier packaging, so it is critical to maintain the integrity of this packaging until the time of use to preserve sterility and prevent contamination.
What are the key differences between the Wingman 14, 14C, 18, and 35 models?
The Wingman models differ primarily by their catheter diameter and intended use in specific vascular segments. While the exact clinical distinctions between the 14, 14C, 18, and 35 models are not detailed in the specifications, the numerical suffixes typically correspond to variations in outer diameter or tip design to accommodate different anatomical challenges. Consult the product documentation for precise model-specific guidance.
Can Wingman catheters be used in MRI environments?
No, Wingman catheters are explicitly stated as not MRI-compatible. This means they should not be used in or near MRI machines, as the magnetic fields could cause damage to the device or pose risks to the patient.
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: wingman 14 wingman 14c wingman 18 wingman 35 - lavascular.com, PDF INGMAN - Reflow Medical, PDF K193596 - Wingman 14, Wingman 14C, Wingman 18, Wingman 35, K193596 FDA 510 (k) - Wingman 14 | 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 | K193596 | Class II | Active |
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Manufacturer
- Manufacturer
- Reflow Medical, Inc.
- FDA Applicant
- Reflow Medical
Sources (1)
- FDA 510(k) K193596 24 fields · synced Oct 1, 2026