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510(k) K010399

DIATEK CANNON-CATH #CC2400, CC2800, CC3200, CC3600,CC5500. CC2400PC, CC2800PC, CC3200PC(32 CM), CC3200PC(36 CM) by Diatek, Inc. — Product Code MSD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 14, 2001
Date Received
February 9, 2001
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 Diatek, Inc.

  • K020430 — DIATEK CONNECTOR ASSEMBLY REPLACEMENT KIT (CARK) (May 9, 2002)
  • K895703 — DIATEK MODEL 700 THERMOMETER (December 7, 1989)
  • K872178 — MODIFICATION TO ARKIVE(TM) (January 27, 1988)
  • K862085 — ARKIVE (TM) (January 12, 1987)
  • K841827 — ENTEROPORT NUTRITION PUMP (July 27, 1984)
  • K841859 — SECURA SET (July 3, 1984)
  • K833568 — DIATEK 600 THERMOMETER SYSTEM (January 10, 1984)
  • K830565 — SECURA SET SECONDARY ADMIN. SET (March 9, 1983)
  • K830355 — SECURA IV VOLUMETRIC INFUSION PUMP (March 1, 1983)
  • K830377 — SECURA SET PRIMARY ADMIN. SET (March 1, 1983)

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)
  • K190527 — GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis Cath (March 5, 2020)
  • K182443 — Pristine Hemodialysis Catheter (May 31, 2019)