Swan-Ganz & Edslab Heparin Coated Cath.

• • Terminated Z-2195-2012 FDA Class II ·initiated 11 May 2012

  The device is being recalled because the firm received multiple complaints related to passage of a J-tip guidewire when inserted through the distal lumen hub of the catheter.

• • Terminated Z-0338-2007 FDA Unclassified (pre-2012) ·initiated 27 Nov 2006

  Misbranding-One lot of Swan-Ganz Thermodilution VIP Catheters, Model 831HF75, lot 246HC197 was labeled with different model information (831F75) on the edge label . The edge label states the model is 831F75 which incorrectly indicates that product does NOT contain an antimicrobial heparin coating. (The tray lid label correctly states the model is 831HF75, containing the heparin coating)

510(k) Number

K812563 ↗

FDA Product Code

DYG

Device Class

Class II

Regulation

21 CFR Part 870.1240

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• American Edwards Small Diameter Rigid Endoscope

  Class II

  FDA 510(k) K851374 Active Cleared 28 Jun 1985

• Swan-Ganz Flow-Directed Thermodil Cath

  Class II

  FDA 510(k) K822350 Active Cleared 24 Aug 1982

• American Edwards Mini-Flex Angioscope

  Class II

  FDA 510(k) K842481 Active Cleared 18 Oct 1984

• Edslab Pressure Gauge

  Class II

  FDA 510(k) K832323 Active Cleared 11 Aug 1983

• Peripheral Dilatation Angioplasty-Cath

  Class II

  FDA 510(k) K834429 Active Cleared 10 Aug 1984

• Forgarty Balloon Calibrator

  Class II

  FDA 510(k) K830734 Active Cleared 12 Apr 1983

See all devices from American Edwards Laboratories →