Essence Guidewire

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

510(k) Number

K955637 ↗

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

• 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

• 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 Essence Guidewire primarily used for in clinical settings?

  The Essence Guidewire is designed for precise navigation within cerebral vasculature, enabling the introduction and positioning of catheters and interventional devices in neurovascular systems. It also supports delivery of therapeutic or diagnostic tools in peripheral and coronary systems, ensuring accurate placement during procedures.

• Is the Essence Guidewire intended for reuse, or is it meant to be used only once?

  The Essence Guidewire is explicitly supplied as a single-use device. While it is not sterile out-of-package, it is intended for use in sterile environments like operating rooms or catheterization labs, where it can be sterilized prior to use if needed.

• How is the Essence Guidewire regulated, and what does its FDA clearance status mean?

  The Essence Guidewire holds an FDA 510(k) clearance (K955637), meaning it has been determined to be substantially equivalent to a legally marketed device already on the market. This clearance falls under the Product Code DQX for neurovascular guidewires and was reviewed by the Cardiovascular (CV) Advisory Committee.

• Can the Essence Guidewire be used in MRI environments, or are there any safety concerns?

  The available data does not specify whether the Essence Guidewire is MRI-safe. If MRI compatibility is required, additional verification from the manufacturer or safety documentation would be necessary before use in such environments.