Envoy Guiding Catheter

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

510(k) Number

K965247 ↗

FDA Product Code

DQY

Device Class

Class II

Regulation

21 CFR Part 870.1250

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

• 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 Envoy Guiding Catheter used for?

  The Envoy Guiding Catheter is an intravascular catheter used to facilitate the introduction and guidance of other devices in neurovascular procedures. It functions as a conduit for secondary devices, allowing access to target vasculature in the peripheral, coronary, and neurovascular systems.

• How is the Envoy Guiding Catheter supplied and is it single-use or reusable?

  The device is supplied as a sterile medical device. The description does not specify whether it is designed for single-use or multiple uses, so clinicians should follow the manufacturer's instructions for use regarding reuse and sterilization protocols.

• What regulatory approvals does the Envoy Guiding Catheter have?

  The Envoy Guiding Catheter was cleared by the FDA through the 510(k) pathway on July 23, 1997, with K number K965247. It is classified as a Class II device under product code DQY and was determined to be substantially equivalent to predicate devices.

• Are there different sizes or models of the Envoy Guiding Catheter available?

  The device data does not specify available sizes or models. Clinicians should consult the manufacturer's product catalog or contact Cordis Neurovascular, Inc. directly for information on specific sizes or models that may be available for different clinical applications.