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510(k) K202150

GlidePath 7.5F Long-Term Dialysis Catheter by C.R. Bard, Inc. — Product Code MSD

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
November 18, 2020
Date Received
August 3, 2020
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

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Other clearances for product code MSD

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  • 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)
  • K202176 — Symetrex LTHD Catheter, Symetrex LTHD Catheter with Sideholes (September 3, 2020)
  • K200627 — GlidePath 10F Long-Term Dialysis Catheter (June 22, 2020)
  • K190527 — GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis Cath (March 5, 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)