Wildcat 5F Guidewire Support Catheter, Mode W500
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K101647 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 Wildcat 5F Guidewire Support Catheter, Mode W500, is a guidewire support catheter (product code DQY) designed to provide enhanced stability and control for steerable guidewires during peripheral vascular interventions. Its flexible yet torqueable construction facilitates precise navigation through complex vascular anatomy, enabling targeted access to discrete regions of the peripheral vasculature. This device is intended for use in interventional radiology and cardiology procedures where guidewire stability is critical.
This catheter is supplied as a single-use, non-sterile device and is intended for use in clinical settings where aseptic techniques are maintained. It is not MRI-safe and must be handled with care to avoid contamination or damage. The Wildcat 5F Guidewire Support Catheter, Mode W500, received FDA 510(k) clearance under the Special 510(k) pathway on August 6, 2010, and is classified as a Class II medical device. Storage should follow manufacturer guidelines to preserve functionality and sterility prior to use.
Frequently asked questions
What is the primary purpose of the Wildcat 5F Guidewire Support Catheter, Mode W500, in clinical procedures?
The Wildcat 5F Guidewire Support Catheter, Mode W500, is designed to enhance stability and control for steerable guidewires during peripheral vascular interventions. Its flexible yet torqueable construction helps navigate complex blood vessels, ensuring precise access to specific areas of the peripheral vasculature, which is particularly useful in interventional radiology and cardiology procedures.
Is the Wildcat 5F Guidewire Support Catheter, Mode W500, intended for single-use or reusable applications?
The Wildcat 5F Guidewire Support Catheter, Mode W500, is explicitly supplied as a single-use device. It is non-sterile and must be used in clinical settings where aseptic techniques are maintained to prevent contamination. Reuse is not recommended or supported by the manufacturer.
How should the Wildcat 5F Guidewire Support Catheter, Mode W500, be stored before use?
The device should be stored according to the manufacturer’s guidelines to preserve its functionality and sterility prior to use. Since it is non-sterile, storage should minimize exposure to contaminants, and the packaging should remain intact until immediate use in a sterile field.
Can this catheter be used in MRI environments, or are there any safety concerns?
The Wildcat 5F Guidewire Support Catheter, Mode W500, is not MRI-safe. It must be handled with care to avoid damage, and its use in MRI environments is not recommended due to potential risks associated with magnetic fields and imaging compatibility.
What regulatory pathway was followed for FDA clearance of the Wildcat 5F Guidewire Support Catheter, Mode W500?
The Wildcat 5F Guidewire Support Catheter, Mode W500, received FDA clearance under the Special 510(k) pathway on August 6, 2010. It was determined to be substantially equivalent to a predicate device and is classified as a Class II medical device, with the review handled by the Cardiovascular (CV) Advisory Committee.
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: wildcat 5f guidewire support catheter mode w500, WILDCAT 5F GUIDEWIRE SUPPORT CATHETER, MODE W500, Wildcat 5F Guidewire Support Catheter - Avinger | FDA Reference
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K101647 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Avinger, Inc.
Sources (1)
- FDA 510(k) K101647 24 fields · synced Sep 20, 2026