Bvi Sling

• • Terminated Z-0352-03 FDA Unclassified (pre-2012) ·initiated 11 Dec 2002 ·on shared 510(k) K002233

  A gap in the exterior seal may lead to sterility concerns with the interior pouch.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K002233 ↗

FDA Product Code

PAJ

Device Class

Class II

Regulation

21 CFR Part 878.3300

Advisory Committee

General, Plastic Surgery

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

• 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

• Dura-Guard Dural Repair Patch, Dura-Guard Dura Substitute

  Class II

  FDA 510(k) K950956 Active Cleared 2 Jun 1995

See all devices from Bio-Vascular, Inc. →