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Wildcat 7F Guidewire Support Catheter

FDA 510(k)

Class II (US FDA 510(k))

510(k) K083313

by Avinger, Inc.

Identifiers

510(k) Number
K083313 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 7F Guidewire Support Catheter is a medical device designed to facilitate the crossing of vascular lesions during endovascular procedures. It provides support and stability to steerable guidewires, enabling precise navigation and access to discrete regions within the peripheral vasculature.

This sterile, single-use, disposable catheter consists of a distal tip, a catheter shaft, and a proximal handle for manipulation and flushing. It is authorized via FDA 510k clearance under K083313.

Frequently asked questions

What is the primary function of the Wildcat 7F Guidewire Support Catheter?

This device is designed to assist clinicians during endovascular procedures by providing necessary support and stability to steerable guidewires. This allows for precise navigation and access to specific regions within the peripheral vasculature when crossing vascular lesions.

Is the Wildcat 7F Guidewire Support Catheter intended for multiple uses?

No, this device is provided as a sterile, single-use, disposable catheter. It is intended to be used for a single procedure and must be discarded afterward to maintain sterility and ensure patient safety.

What is the regulatory status of this catheter?

The Wildcat 7F Guidewire Support Catheter has received FDA 510k clearance under K083313. This indicates that the device has been determined to be substantially equivalent to legally marketed predicate devices for its intended use in peripheral vascular procedures.

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 7F Guidewire Support Catheter - Avinger | FDA Reference, WILDCAT 7F GUIDEWIRE SUPPORT CATHETER - Innolitics, PDF O000 I0 - Food and Drug Administration, PDF K083313 - Wildcat 7f Guidewire Support Catheter

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Avinger, Inc.

Sources (1)

  • FDA 510(k) K083313 24 fields · synced Sep 27, 2026