Cardiac Pathways Reference Catheter and Reference Catheter with Tracking, Cardiac Pathways Radii Catheter and Radii Cath

• • Terminated Z-0112-06 FDA Unclassified (pre-2012) ·initiated 14 Mar 2005 ·on shared 510(k) K992912

  The device has the potential for overheating its transformer and has the potential for fire hazard.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K992912 ↗

FDA Product Code

DRF

Device Class

Class II

Regulation

21 CFR Part 870.1220

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Mercator Atrial High Density Array Catheter; Cardiac Pathways Egm Adapter Cables

  Class II

  FDA 510(k) K990795 Active Cleared 8 Jun 1999

• Mercator Atrial High Density Array Catheter Models, 7005, 7006, 7007, Mercator Atrial High Density Array Deployment Kit,

  Class II

  FDA 510(k) K982540 Active Cleared 27 Jan 1999

• Arrhythmia Mapping System (8100/8300)

  Class II

  FDA 510(k) K965066 Active Cleared 11 Aug 1997

• Radii Diagnostic Electrophysiology Catheter, Model # 30411 B, C and D

  Class II

  FDA 510(k) K983653 Active Cleared 22 Dec 1998