Tissue Patch, Tissue Graft

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K921895 ↗

FDA Product Code

DXZ

Device Class

Class II

Regulation

21 CFR Part 870.3470

Advisory Committee

Cardiovascular

FDA Decision

SESP Substantially Equivalent — Postmarket Surveillance

• 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

• 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. →