Agility Steerable Guidewire

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K991646 ↗

FDA Product Code

DQX

Device Class

Class II

Regulation

21 CFR Part 870.1330

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Prowler Select 10 and 14 Infusion Catheters with and Without Pre-Shaped Tips

  Class II

  FDA 510(k) K020680 Active Cleared 27 Mar 2002

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  FDA 510(k) K082324 Active Cleared 12 Sep 2008

• Essence Guidewire

  Class II

  FDA 510(k) K955637 Active Cleared 11 Mar 1996

• Trufill Dcs Orbit Detachable Coil System Line Extension

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  FDA 510(k) K053197 Active Cleared 15 Dec 2005

• Envoy Guiding Catheter

  Class II

  FDA 510(k) K965247 Active Cleared 23 Jul 1997

• Transit-2 Infusion Catheter

  Class II

  FDA 510(k) K950909 Active Cleared 16 May 1995

See all devices from Cordis Neurovascular, Inc. →

• What is the Agility Steerable Guidewire used for?

  The Agility Steerable Guidewire is used for directing catheters through blood vessels to facilitate selective placement of microcatheters and other devices within the neuro and peripheral vasculature.

• How is the Agility Steerable Guidewire supplied?

  The guidewire is supplied with a product code of DQX and is classified as a catheter guide wire.

• Is the Agility Steerable Guidewire single-use or reusable?

  The device description does not specify whether the Agility Steerable Guidewire is single-use or reusable, but it is designed for use in percutaneous procedures.

• What regulatory authorization does the Agility Steerable Guidewire have?

  The Agility Steerable Guidewire has an FDA 510(k) authorization, indicating it has been found substantially equivalent to a predicate device.