Dardik Biograft Human Umbilical Vein Graft

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

Full name

Dardik Biograft(R) Mod. Human Umbilical Vein Graft

Trade Name

Dardik Biograft

Generic Name

Tissue graft of 6mm and greater

PMA Number

P780002 ↗

FDA Product Code

LXA

Device Class

Class III

Advisory Committee

Cardiovascular

FDA Decision

APWD Approval withdrawn

• Veritas Collagen Matrix

  Class II

  FDA 510(k) K030879 Active Cleared 24 Apr 2003

• Synovis Collagen Matrix (Tbd)

  Class II

  FDA 510(k) K122306 Active Cleared 8 Mar 2013

• Peri-Strips Staple Line Reinforcement - Sleeve and Strip Configurations - and Peri-Strips Dry Staple Line Reinforcement

  Class II

  FDA 510(k) K040415 Active Cleared 14 Apr 2004

• Steerable Stylet

  Class II

  FDA 510(k) K040001 Active Cleared 9 Mar 2004

• Veritas Collagen Matrix (Dry)

  Class II

  FDA 510(k) K083039 Active Cleared 26 Nov 2008

• Veritas Dry Collagen Matrix, Veritas Dry or Veritas Psd

  Class II

  FDA 510(k) K041669 Active Cleared 27 Oct 2004

See all devices from Synovis Surgical Innovations →