Ilt Support Catheter .014, Model C114LW1; Ilt Support Catheter Advancing Mechanism, Model A11AM1

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

510(k) Number

K012169 ↗

FDA Product Code

DQY

Models / Variants

Ilt Support Catheter .014, Model C114LW1

Ilt Support Catheter Advancing Mechanism, Model A11AM1

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. →