Vanguard Reprocessed Pulse Oximeter Sensors

• 3 recalls, same reason

  • Terminated Z-1683-2008 FDA Unclassified (pre-2012) ·initiated 11 Mar 2008
  • Terminated Z-1663-2008 FDA Unclassified (pre-2012) ·initiated 11 Mar 2008
  • Terminated Z-1664-2008 FDA Unclassified (pre-2012) ·initiated 11 Mar 2008

  Sterility Compromised -- Ascent Healthcare Solutions cannot validate the sterilization process for a variety of Ascent Healthcare Solutions products.

510(k) Number

K012344 ↗

FDA Product Code

NLF

Device Class

Class II

Regulation

21 CFR Part 870.2700

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Vanguard Reprocessed Non-Electric Biopsy Forceps

  Class I

  FDA 510(k) K042594 Active Cleared 25 Jan 2005

• Vanguard Reprocessed Femoral Compression Device

  Class II

  FDA 510(k) K011832 Active Cleared 21 Dec 2001

• Vanguard Reprocessed Diagnostic Electrophysiology Catheters

  Class II

  FDA 510(k) K042074 Active Cleared 9 Mar 2005

• Vanguard Reprocessed Compression Garment

  Class II

  FDA 510(k) K012403 Active Cleared 17 Oct 2001

• Reprocessed Disposable Cutters, Staplers and Appliers

  Class II

  FDA 510(k) K032973 Active Cleared 18 Dec 2003

• Vanguard Reprocessed Dilating Tip and Blunt Trocars

  Class II

  FDA 510(k) K043253 Active Cleared 8 Apr 2005

See all devices from Vanguard Medical Concepts, Inc. →