Agility Steerable Guidewire

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

510(k) Number

K001033 ↗

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

• Trufill Dcs Syringe

  Class II

  FDA 510(k) K082324 Active Cleared 12 Sep 2008

• Essence Guidewire

  Class II

  FDA 510(k) K955637 Active Cleared 11 Mar 1996

• Agility Steerable Guidewire

  Class II

  FDA 510(k) K991646 Active Cleared 23 Sep 1999

• Trufill Dcs Orbit Detachable Coil System Line Extension

  Class II

  FDA 510(k) K053197 Active Cleared 15 Dec 2005

• Envoy Guiding Catheter

  Class II

  FDA 510(k) K965247 Active Cleared 23 Jul 1997

See all devices from Cordis Neurovascular, Inc. →

• Is the Agility Steerable Guidewire designed for single-use or can it be reused in multiple procedures?

  The Agility Steerable Guidewire is explicitly labeled as a reusable medical instrument, meaning it is intended for repeated use across multiple angiographic procedures. This classification aligns with its design as a durable, coiled wire meant to navigate blood vessels for selective catheter placement in neurovascular and peripheral vasculature.

• What types of vascular procedures is this guidewire primarily intended to assist with?

  The Agility Steerable Guidewire is designed to facilitate precise navigation through blood vessels during angiographic procedures, enabling selective access to lesions or vessel segments. Its steerable design supports interventions in both neurovascular and peripheral vasculature, making it suitable for procedures requiring careful catheter placement.

• How is the Agility Steerable Guidewire supplied, and does it come in multiple sizes or models?

  The device data does not specify individual sizes or models, but as a reusable guidewire, it is supplied as a single instrument intended to fit within percutaneous catheters. The steerable design suggests flexibility in navigating varied vascular paths, though exact configurations (e.g., length, tip flexibility) would typically be detailed in the product documentation or packaging.

• What regulatory pathway was followed for FDA clearance of this guidewire, and what does that mean for its use?

  The Agility Steerable Guidewire received FDA 510(k) clearance under Special classification (K001033), with no third-party review. This means the manufacturer demonstrated that the device is substantially equivalent to a legally marketed predicate device for cardiovascular applications, specifically under the DQX product code for catheter guide wires. Clinically, this clearance indicates compliance with regulatory standards for neurovascular and peripheral vascular interventions.