Torque Tube Steerocath(Tm)

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K913375 ↗

FDA Product Code

DRF

Device Class

Class II

Regulation

21 CFR Part 870.1220

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Map Dc-Coupled Isolated Preamplifier Model #1001

  Class II

  FDA 510(k) K885252 Active Cleared 13 Jan 1989

• Tracfinder II

  Class II

  FDA 510(k) K924108 Active Cleared 16 Dec 1993

• Franz Steerable Combination Catheter

  Class II

  FDA 510(k) K903880 Active Cleared 12 Oct 1990

• Diagnostic II Catheter

  Class II

  FDA 510(k) K940168 Active Cleared 27 Jul 1994

• Quattro Catheter

  Class II

  FDA 510(k) K900452 Active Cleared 14 Mar 1990

• Astronomer Plus System

  Class II

  FDA 510(k) K013349 Active Cleared 9 Apr 2002

See all devices from Ep Technologies, Inc. →