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510(k) K151177

XenMatrix AB Surgical Graft by C. R. Bard — Product Code PIJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 2015
Date Received
May 1, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Collagen Surgical Mesh Containing Drugs
Device Class
Class II
Regulation Number
878.3300
Review Panel
SU
Submission Type

Reinforcement of soft tissue where weakness exists.

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  • K182281 — Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Ne (October 24, 2018)
  • K172571 — ULTRASCORE Focused Force PTA Balloon (September 22, 2017)
  • K170294 — VENTRALIGHT ST Mesh with ECHO 2 Positioning System 11cm (4.5”) Circle, VENTRALIG (May 1, 2017)
  • K162193 — XenMatrix AB Surgical Graft (December 23, 2016)
  • K142818 — Phasix Mesh (March 31, 2015)
  • K140501 — XENMATRIX SURGICAL GRAFT (April 28, 2014)
  • K112791 — SITESCRUB IPA DEVICE (February 24, 2012)

Other clearances for product code PIJ

  • K162193 — XenMatrix AB Surgical Graft (December 23, 2016)
  • K133223 — XENMATRIX AB SURGICAL GRAFT (September 19, 2014)