Dura-Guard - Dural Repair Patch

• • Terminated Z-0339-2014 FDA Class II ·initiated 28 Oct 2013

  Synovis, a subsidiary of Baxter International Inc., is recalling certain shipments of VASCUGUARD and DURA-GUARD because Synovis, a subsidiary of Baxter International Inc., is recalling certain shipments of VASCUGUARD and DURA-GUARD because the shipping configurations in which the 6 fluid ounce units containing a specific revision of the Instructions for Use (IFU) shipped in a divided cell shipping

510(k) Number

K982282 ↗

FDA Product Code

GXQ

Device Class

Class II

Regulation

21 CFR Part 882.5910

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

• Tissue Patch, Tissue Graft

  Class II

  FDA 510(k) K921895 Active Cleared 4 Nov 1992

• Peri-Strips Dry - Staple Line Reinforcement

  Class II

  FDA 510(k) K971048 Active Cleared 9 May 1997

• Vascu-Guard

  Class II

  FDA 510(k) K942010 Active Cleared 7 Jul 1994

• Bvi Sling

  Class II

  FDA 510(k) K002233 Active Cleared 13 Oct 2000

• Peri-Guard Pericardium

  Class II

  FDA 510(k) K961811 Active Cleared 13 Jun 1996

• Peri-Guard, Cv Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips - Sleeve, Peri-Strips-Strips, Peri-Strips Dry, Vasc Open recall

  Class II

  FDA 510(k) K983162 Active Cleared 9 Oct 1998

See all devices from Bio-Vascular, Inc. →