Home / 510(k) Clearances / K010399

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

K010399 is an FDA 510(k) premarket notification submitted by Diatek, Inc. for the device "DIATEK CANNON-CATH #CC2400, CC2800, CC3200, CC3600,CC5500. CC2400PC, CC2800PC, CC3200PC(32 CM), CC3200PC(36 CM)". The FDA issued a decision of Substantially Equivalent on August 14, 2001. The device falls under product code MSD (Catheter, Hemodialysis, Implanted), a Class II device regulated under 21 CFR 876.5540. Diatek, Inc. has at least 10 other 510(k) clearances on record.

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)
  • K830377 — SECURA SET PRIMARY ADMIN. SET (March 1, 1983)
  • K830355 — SECURA IV VOLUMETRIC INFUSION PUMP (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)

FDA data resources