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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 Aug 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 12 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Aug 28, 1996
Date Received
Oct 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
510(k)

Other clearances by Gambro Healthcare

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

Other clearances for product code FKT

  • K123835 — 2008 HEMODIALYSIS SORBENT SYSTEM (Feb 15, 2013)
  • K093362 — 2008 HEMODIALYSIS SORBENT SYSTEM (Aug 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 (Jun 3, 2005)
  • K031099 — SORB+HISORB+CARTRIDGE (Sep 17, 2003)
  • K882428 — REDY 2000 (Oct 25, 1988)
  • K874137 — MODIFIED BIOLOGIC 1000 HEMODIAL. & HD-1000 DIS CAR (Apr 8, 1988)
  • K870270 — MODIFIED BIO. HEMODIALYSIS & HD-1000 DISP. CART. (Feb 25, 1987)
  • K864179 — BIOLOGIC 1000 HEMODIALYSIS MACH/HD-1000 DISP CARTR (Dec 11, 1986)

FDA data resources

Source: FDA 510(k) database entry for K954623. Report a data issue: hello@regdatalab.com.