Cordis Webster A20 Diagnostic Deflectable Tip Catheter

• 2 recalls, same reason

  • Terminated Z-2665-2011 FDA Unclassified (pre-2012) ·initiated 23 May 2011
  • Terminated Z-2664-2011 FDA Unclassified (pre-2012) ·initiated 23 May 2011

  The recall was initiated because Biosense Webster, Inc. has recently become aware that 20 electrodes catheters with Auto ID Technology are not being recognized when connected to the CARTO 3 System.

• • Terminated Z-3037-2011 FDA Unclassified (pre-2012) ·initiated 29 Apr 2011

  The recall was expanded because between February and April 2011, Biosense Webster, Inc. notified customers that a voluntary Customer Notification had been Initiated due to the inaccessibility of the electronic version of the Instructions for Use (e-IFU) for the "10 ft. Interface Cable, 10 Pin - Shielded Tip Pins to 12 Pin - Blue", Catalog Number D128709, through the J&J Gateway (i.e., e-IFU websi

• • Terminated Z-3038-2011 FDA Unclassified (pre-2012) ·initiated 29 Apr 2011

  The recall was expanded because between February and April 2011, Biosense Webster, Inc. notified customers that a voluntary Customer Notification had been Initiated due to the inaccessibility of the electronic version of the Instructions for Use (e-IFU) for the "10 ft. Interface Cable, 10 Pin - Shielded Tip Pins to 12 Pin - Blue", Catalog Number 0128709, through the J&J Gateway (i.e., e-IFU websi

510(k) Number

K953768 ↗

FDA Product Code

DRF

Device Class

Class II

Regulation

21 CFR Part 870.1220

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Cordis Wester Star Catheter

  Class II

  FDA 510(k) K954390 Active Cleared 21 Dec 1995

• Cordis Webster Ref-Star Ex Surface Reference Device Model's D-1204-01, -02, -03, and -04.

  Class II

  FDA 510(k) K980961 Active Cleared 28 May 1998

• Cordis Webster Fixed Curve Catheters, Models D-1124, D-1085

  Class II

  FDA 510(k) K992965 Active Cleared 26 Nov 1999

• Coridis Webster Deflectable Braided-Tip Electrode Catheter

  Class II

  FDA 510(k) K955817 Active Cleared 25 Mar 1996

• Cordis Webster Ref-Star External Reference Patch, Model # D-1210

  Class II

  FDA 510(k) K982415 Active Cleared 10 Aug 1998

• Webster Diagnostic Deflectable Tip Catheter, Model D-1078

  Class II

  FDA 510(k) K991531 Active Cleared 4 Oct 1999

See all devices from Cordis Webster, Inc. →