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

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

510(k) Number

K982540 ↗

FDA Product Code

MTD

Device Class

Class II

Regulation

21 CFR Part 870.1220

Advisory Committee

Cardiovascular

FDA Decision

SESU

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

  Class II

  FDA 510(k) K990795 Active Cleared 8 Jun 1999

• Arrhythmia Mapping System (8100/8300)

  Class II

  FDA 510(k) K965066 Active Cleared 11 Aug 1997

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

  Class II

  FDA 510(k) K992912 Active Cleared 8 Mar 2000

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

  Class II

  FDA 510(k) K983653 Active Cleared 22 Dec 1998