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510(k) K020430

DIATEK CONNECTOR ASSEMBLY REPLACEMENT KIT (CARK) by Diatek, Inc. — Product Code NFK

K020430 is an FDA 510(k) premarket notification submitted by Diatek, Inc. for the device "DIATEK CONNECTOR ASSEMBLY REPLACEMENT KIT (CARK)". The FDA issued a decision of Substantially Equivalent on May 9, 2002. The device falls under product code NFK (Kit, Repair, Catheter, Hemodialysis), 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
May 9, 2002
Date Received
February 8, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kit, Repair, Catheter, Hemodialysis
Device Class
Class II
Regulation Number
876.5540
Review Panel
GU
Submission Type

Hemodialysis Tray

Other clearances by Diatek, Inc.

  • K010399 — DIATEK CANNON-CATH #CC2400, CC2800, CC3200, CC3600,CC5500. CC2400PC, CC2800PC, C (August 14, 2001)
  • 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 NFK

  • K101261 — CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000 (July 29, 2010)
  • K092797 — ACUTE AND CHRONIC CATHETER REPAIR KIT (November 19, 2009)
  • K063446 — CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000 (December 15, 2006)
  • K062435 — REPAIR KIT FOR XPRESSO, DECATHLON, AND ALTA LR CATHETERS (December 5, 2006)
  • K030442 — CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000 (July 21, 2003)
  • K022644 — RETRO REPAIR KIT, MODEL PRRK5 (November 6, 2002)
  • K022570 — MEDCOMP REPAIR KIT, MODEL ASPCRPK (October 31, 2002)
  • K022561 — CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000 (August 23, 2002)
  • K011015 — CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000 (June 22, 2001)
  • K011576 — MEDCOMP ASH SPLIT (June 21, 2001)

FDA data resources