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Steerable Guide Catheter

FDA 510(k)

Class II (US FDA 510(k))

510(k) K172394

by Abbott Vascular

Identifiers

510(k) Number
K172394 FDA 510(k)
FDA Product Code
DRA FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.1280 FDA 510(k)
Regulation Number
870.1280 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Steerable Guide Catheter is a medical device designed to facilitate the introduction and positioning of delivery systems within the cardiovascular system. It is specifically used to navigate through the interatrial septum and orient delivery components to target locations, such as the area above the mitral valve.

This device is provided ethylene oxide sterile and includes a dilator as part of the system. It is regulated under FDA 510(k) clearance, identified by K172394, and falls under the cardiovascular medical specialty.

Frequently asked questions

What is the primary clinical use of the Steerable Guide Catheter?

This device is designed to facilitate the introduction and positioning of delivery systems within the cardiovascular system. It allows clinicians to navigate through the interatrial septum and orient delivery components to specific target locations, such as the area above the mitral valve.

How is the device supplied to the clinical setting?

The Steerable Guide Catheter is provided ethylene oxide sterile to ensure it is ready for use in a clinical environment. The system also includes a dilator as part of the package to assist with the introduction process.

What is the regulatory status of this catheter?

The Steerable Guide Catheter is regulated under FDA 510(k) clearance, identified by K172394. This indicates that the device has been reviewed and found to be substantially equivalent to other legally marketed devices within the cardiovascular medical specialty.

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: TigerWire™ Guidewires | Abbott, Catheters | Abbott, PDF Abbott MitraClip Clip Delivery System - U.S., PDF 5 10(k) SUMMARY AG3121 - Food and Drug Administration

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Abbott Vascular

Sources (1)

  • FDA 510(k) K172394 24 fields · synced Sep 22, 2026