FOX PTA CATHETER, 3.0, 4.0, 5.0, 6.0, 7.0, AND 8.0 X 40 MM - A14007

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

510(k) Number

K010838 ↗

FDA Product Code

DQY

Models / Variants

A14003

A14004

A14005

A14006

A14007

A14008

Device Class

Class II

Regulation

21 CFR Part 870.1250

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Jowire Neo's Ptca Catheter Guidewires, Models AG141000, AG142000, AG143000, AG141002, AG141010, AG14M060 & AG14M050

  Class II

  FDA 510(k) K022762 Active Cleared 16 Dec 2002

• Smartwire/Smartmap Pressure System

  Class II

  FDA 510(k) K021219 Active Cleared 17 May 2002

• In-Vision Imaging System

  Class II

  FDA 510(k) K031148 Active Cleared 28 May 2003

• Jovus Eagle Eye F/X 2.9F Ivus Catheter, Model 85900

  Class II

  FDA 510(k) K031346 Active Cleared 23 Jun 2003

• Modification to Fox PTA Catheter

  Class II

  FDA 510(k) K020854 Active Cleared 11 Apr 2002

• Trak Back II

  Class II

  FDA 510(k) K003938 Active Cleared 18 Jan 2001

See all devices from Jomed AG →