Safe-Cross Radio Frequency Total Occlusion Crossing System

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

Full name

Modification to Safe-Cross Radio Frequency Total Occlusion Crossing System

510(k) Number

K033929 ↗

FDA Product Code

DQX

Device Class

Class II

Regulation

21 CFR Part 870.1330

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

• Ilt Torquer, Model 114TR1

  Class II

  FDA 510(k) K021243 Active Cleared 11 Jul 2002

See all devices from Intra Luminal Therapeutics, Inc. →

• What is the primary clinical purpose of this device in vascular procedures?

  This device is specifically designed to help physicians cross total occlusions in native peripheral arteries during vascular interventions. It uses radio frequency energy to create a controlled pathway through chronic blockages, allowing subsequent placement of therapeutic or diagnostic tools like stents or catheters.

• Is this device intended for reuse in clinical settings, or is it meant to be used only once?

  The device is explicitly labeled for single-use in clinical settings, meaning it should not be reused after one procedure. This aligns with standard safety practices for invasive medical devices to prevent contamination or degradation of performance.

• How was this modification to the original SAFE-CROSS system approved by the FDA?

  The modification received FDA 510(k) clearance under Special Review (K033929) as a Class II device (product code DQX), demonstrating that it was determined to be substantially equivalent to a legally marketed predicate device. The review was conducted by the Cardiovascular (CV) Advisory Committee in 2004.

• Are there any specific storage instructions provided for this device?

  The provided data does not include details on storage conditions, such as temperature or shelf life. However, since it is a single-use device, it should be stored in its original packaging until use and handled according to standard sterile medical device protocols to maintain integrity.