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510(k) K072499

NOVOFLO CATHETER LT by Novosci, Inc. — Product Code MSD

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
October 30, 2007
Date Received
September 5, 2007
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 Novosci, Inc.

  • K063355 — D-LINE CATHETER ST, DOUBLE LUMEN ST; EXTRA FLOW (July 27, 2007)
  • K033270 — NOVOSCI READY SYSTEM, MODEL RS-200 (February 13, 2004)
  • K033328 — NOVOSCI TUBING AND CONNECTORS WITH NOVOCOAT TREATMENT (January 16, 2004)

Other clearances for product code MSD

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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)