Safe-Cross Radio Frequency Total Occlusion Crossing System [Peripheral]

No FDA recalls found in the data synced 9 Oct 2026.

510(k) Number

K050916 ↗

FDA Product Code

PDU

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. →