Vanguard Reprocessed Femoral Compression Device

• • Terminated Z-2196-2010 FDA Unclassified (pre-2012) ·initiated 23 Jun 2010

  The FemoStop Devices may fail to inflate or hold pressure. A separation between the dome and arch base prevents the device from maintaining pressure when inflated.

510(k) Number

K011832 ↗

FDA Product Code

NMF

Device Class

Class II

Regulation

21 CFR Part 870.4450

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 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

• Vanguard Reprocessed External Fixation Devices

  Class II

  FDA 510(k) K031687 Active Cleared 30 Apr 2004

See all devices from Vanguard Medical Concepts, Inc. →