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510(k) K092205

PALINDROME P HEMODIALYSIS CATHETER by Covidien Lp, Formerly Registered AS Kendall — Product Code MSD

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
October 30, 2009
Date Received
July 22, 2009
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 Covidien Lp, Formerly Registered AS Kendall

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  • K112511 — DOBBHOFF DUAL PORT FEEDING TUBE (May 11, 2012)

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  • 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)
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  • 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)