Electrode Switchbox, Model 11-081002

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

510(k) Number

K982835 ↗

FDA Product Code

DRF

Device Class

Class II

Regulation

21 CFR Part 870.1220

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Cardima Vueport Coronary Sinus Balloon Occlusion Guiding Catheter

  Class II

  FDA 510(k) K973298 Active Cleared 26 Jun 1998

• Naviport Deflectable Tip Guiding Catheter

  Class II

  FDA 510(k) K974683 Active Cleared 22 Jun 1999

• Tracer O-T-W Mapping Device

  Class II

  FDA 510(k) K972803 Active Cleared 11 May 1999

• Modification to: Cardima Ablation System

  Class II

  FDA 510(k) K060715 Active Cleared 15 May 2006

• Pathfinder

  Class II

  FDA 510(k) K955802 Active Cleared 29 Jan 1997

• Cardima Pathfinder 1.5F Mapping Microcatheter

  Class II

  FDA 510(k) K971975 Active Cleared 1 Jul 1998

See all devices from Cardima, Inc. →