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510(k) K905388

COBE CENTRYSYSTEM 3 BICART OPTION KIT by Cobe Laboratories, Inc. — Product Code FKP

K905388 is an FDA 510(k) premarket notification submitted by Cobe Laboratories, Inc. for the device "COBE CENTRYSYSTEM 3 BICART OPTION KIT". The FDA issued a decision of Substantially Equivalent on February 11, 1991. The device falls under product code FKP (System, Dialysate Delivery, Single Patient), a Class II device regulated under 21 CFR 876.5820. Cobe Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 11, 1991
Date Received
November 30, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Dialysate Delivery, Single Patient
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

Other clearances by Cobe Laboratories, Inc.

  • K923272 — COBE CMS-HF HOLLOW FIBER MEMBRANE OXYGENATOR (May 11, 1993)
  • K900105 — COBE SPECTRA BLOOD COMPONENT SEPARATOR THERAPEUTIC (March 22, 1991)
  • K905793 — COBE CENTRY 2 BICART OPTION KIT (February 12, 1991)
  • K904336 — NEW COBE SATURATION/HEMATOCRIT MONITOR (December 27, 1990)
  • K902631 — COBE ICU CONVERSION KIT (December 17, 1990)
  • K902437 — COBE CARDIOTOMY RESERVOIR WITH OR WITHOUT FILTER (December 17, 1990)
  • K904566 — NEW COBE CENTRYSYSTEM(TM) 100 HG DIALYZER (December 12, 1990)
  • K902758 — COBE SATURATION/HEMATOCRIT MONITOR W/ FIBER OPTIC (August 23, 1990)
  • K902759 — COBE CLOSED WOUND DRAINAGE KIT (July 18, 1990)
  • K902671 — COBE AUTOLOGOUS BLOOD SALVAGE RESERV W/W/O FILTER (July 17, 1990)

Other clearances for product code FKP

  • K181991 — NxStage Connected Health System (September 26, 2018)
  • K131739 — NXSTAGE CONNECTED HEALTH SYSTEM (October 10, 2013)
  • K130460 — NXSTAGE DOSING CALCULATOR (July 11, 2013)
  • K040074 — ONEVIEW INTERFACE (April 8, 2004)
  • K021060 — FRESENIUS ICARE MONITORING SYSTEM (November 13, 2002)
  • K003615 — STERICHEK SENSITIVE-FEED WATER AND RINSE WATER REAGENT STRIPS (February 1, 2001)
  • K992255 — CKHEMO, MODEL CKHEMO VERSION 1.0 (November 30, 1999)
  • K964264 — HIGH RANGE PEROXIDE TEST STRIP (June 16, 1997)
  • K955423 — PACK H HEMODIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM (June 13, 1996)
  • K953854 — WATERCHECK REAGENT STRIP FOR CHLORINE & PEROXIDE (March 11, 1996)

FDA data resources