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510(k) K162193

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 2016
Date Received
August 4, 2016
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.

Other clearances by C. R. Bard

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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)
  • K151177 — XenMatrix AB Surgical Graft (July 30, 2015)
  • 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

  • K151177 — XenMatrix AB Surgical Graft (July 30, 2015)
  • K133223 — XENMATRIX AB SURGICAL GRAFT (September 19, 2014)