Safe-Cross Deflecting Catheter, Model C114ND1

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

Full name

Ilt Safe-Cross Deflecting Catheter, Model C114ND1

510(k) Number

K032784 ↗

FDA Product Code

DQY

Device Class

Class II

Regulation

21 CFR Part 870.1250

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Ilt 0.014 Catheter, Model C114NL2

  Class II

  FDA 510(k) K001992 Active Cleared 25 Sep 2000

• Safe-Cross Radio Frequency Total Occlusion Crossing System [Coronary]

  Class II

  FDA 510(k) K050915 Active Cleared 7 Jun 2005

• Ilt Deflecting Catheter, Model C114ND1

  Class II

  FDA 510(k) K010531 Active Cleared 18 Apr 2001

• Safe-Cross Deflecting Catheter, Model C118ND1

  Class II

  FDA 510(k) K040481 Active Cleared 18 Mar 2004

• Safe-Steer Guide Wire System

  Class II

  FDA 510(k) K011986 Active Cleared 3 Apr 2002

• Safe-Cross Radio Frequency Total Occlusion Crossing System

  Class II

  FDA 510(k) K033929 Active Cleared 12 Jan 2004

See all devices from Intra Luminal Therapeutics, Inc. →

• Is the ILT Safe-Cross Deflecting Catheter, Model C114ND1, intended for single-use or can it be reused in multiple procedures?

  The ILT Safe-Cross Deflecting Catheter, Model C114ND1, is explicitly described as a reusable device and is designed for use in clinical settings like catheterization laboratories. This means it can be cleaned, sterilized, and reused for subsequent procedures, provided proper reprocessing protocols are followed.

• What types of procedures is this catheter primarily used for, and what role does it play in those procedures?

  This catheter is designed for vascular access and navigation, specifically to assist in placing guide wires and other interventional devices within blood vessels. It enhances procedural flexibility during interventional cardiology or vascular procedures, allowing precise access to specific regions of the vasculature. It can also deliver saline solutions or diagnostic contrast agents alongside its guiding function.

• How is the ILT Safe-Cross Deflecting Catheter, Model C114ND1, regulated, and what classification does it hold?

  The device received FDA clearance through the 510(k) pathway and is classified as a Class 2 medical device. The clearance was granted under the Cardiovascular (CV) advisory committee and is substantiated as substantially equivalent to a predicate device. The product code assigned is DQY, which categorizes it within vascular access and navigation devices.

• Does the ILT Safe-Cross Deflecting Catheter, Model C114ND1, come with any specific sterility guarantees or MRI safety information?

  The provided data does not specify any sterility guarantees for this catheter, nor does it mention MRI safety information. Since it is a reusable device, sterility would depend on proper reprocessing protocols in the clinical setting. Always verify sterility and safety requirements with the manufacturer or local guidelines before use.