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510(k) K140884

SYMETREX LONG TERM HEMODIALYSIS CATHETER by Phase One Medical — Product Code MSD

K140884 is an FDA 510(k) premarket notification submitted by Phase One Medical for the device "SYMETREX LONG TERM HEMODIALYSIS CATHETER". The FDA issued a decision of Substantially Equivalent (kit) on November 26, 2014. The device falls under product code MSD (Catheter, Hemodialysis, Implanted), a Class II device regulated under 21 CFR 876.5540.

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
November 26, 2014
Date Received
April 7, 2014
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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  • 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)
  • K190527 — GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis Cath (March 5, 2020)
  • K182443 — Pristine Hemodialysis Catheter (May 31, 2019)

FDA data resources