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510(k) K954623

REDY 2000 SYSTEM (THERAPEUTIC PLASMA EXCHANGE OPTION AND MONITORING LINE Y-CONNECTOR) by Gambro Healthcare — Product Code FKT

K954623 is an FDA 510(k) premarket notification submitted by Gambro Healthcare for the device "REDY 2000 SYSTEM (THERAPEUTIC PLASMA EXCHANGE OPTION AND MONITORING LINE Y-CONNECTOR)". The FDA issued a decision of Substantially Equivalent on August 28, 1996. The device falls under product code FKT (System, Dialysate Delivery, Sorbent Regenerated), a Class II device regulated under 21 CFR 876.5600. Gambro Healthcare has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 28, 1996
Date Received
October 5, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Dialysate Delivery, Sorbent Regenerated
Device Class
Class II
Regulation Number
876.5600
Review Panel
GU
Submission Type

Other clearances by Gambro Healthcare

  • K994390 — GAMBRO POLYFLUX 17R, CAPILLARY DIALYZER/ FILTER (October 26, 2000)
  • K990039 — GAMBRO DQM 200 (January 27, 2000)
  • K982413 — COBE ARYLANE H1, H4, H6 & H9 HEMODIALYZERS/FILTERS (April 21, 1999)
  • K982414 — GAMBRO POLYFLUX 11S, 14S, 17S & 21S HEMODIALYZERS/ HEMOFILTERS (March 26, 1999)
  • K980386 — HOSPAL MULTIFLOW 100, MULTIFLOW 100 KITS A0 (A0,A0/B AND A0/0), MULTIFLOW 100 KI (February 24, 1999)
  • K982760 — COBE C HEMODIALYSIS DELIVERY SYSTEM , COBE CARTRIDGE BLOOD TUBING SET (November 4, 1998)
  • K982818 — HOSPAL TIPSTOP (October 21, 1998)
  • K974899 — GAMBRO CENTRAL WATER TREATMENT SYSTEM CWP 100 - WRO H (September 23, 1998)
  • K981681 — PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM) (August 11, 1998)
  • K981085 — GAMBRO HEMODIALYSIS WATER TREATMENT SYSTEM (May 18, 1998)

Other clearances for product code FKT

  • K123835 — 2008 HEMODIALYSIS SORBENT SYSTEM (February 15, 2013)
  • K093362 — 2008 HEMODIALYSIS SORBENT SYSTEM (August 13, 2010)
  • K070739 — ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL# 1500 (May 25, 2007)
  • K060381 — ALLIENT SORBET HEMODIALYSIS SYSTEM, MODEL 1100 (May 24, 2006)
  • K043574 — ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL 1000 (June 3, 2005)
  • K031099 — SORB+HISORB+CARTRIDGE (September 17, 2003)
  • K882428 — REDY 2000 (October 25, 1988)
  • K874137 — MODIFIED BIOLOGIC 1000 HEMODIAL. & HD-1000 DIS CAR (April 8, 1988)
  • K870270 — MODIFIED BIO. HEMODIALYSIS & HD-1000 DISP. CART. (February 25, 1987)
  • K864179 — BIOLOGIC 1000 HEMODIALYSIS MACH/HD-1000 DISP CARTR (December 11, 1986)

FDA data resources