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510(k) K190527

GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis Catheters, HemoStar XK Long-Term Hemodialysis Catheters by C. R. Bard — Product Code MSD

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
March 5, 2020
Date Received
March 4, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Hemodialysis, Implanted
Device Class
Class II
Regulation Number
876.5540
Review Panel
GU
Submission Type

Other clearances by C. R. Bard

  • 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)
  • 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 MSD

  • K241581 — Hemodialysis Catheter (May 16, 2025)
  • K210461 — End Cap (September 14, 2021)
  • K203575 — GlidePath Retro Long-Term Hemodialysis Catheter (July 1, 2021)
  • K211410 — GlidePath 13F Long-Term Hemodialysis Catheter (June 4, 2021)
  • K203767 — Pristine Long-Term Hemodialysis Catheter (April 2, 2021)
  • K202150 — GlidePath 7.5F Long-Term Dialysis Catheter (November 18, 2020)
  • K202176 — Symetrex LTHD Catheter, Symetrex LTHD Catheter with Sideholes (September 3, 2020)
  • K200627 — GlidePath 10F Long-Term Dialysis Catheter (June 22, 2020)
  • K182443 — Pristine Hemodialysis Catheter (May 31, 2019)
  • K173667 — 15.5F X 19 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 2 (May 17, 2018)