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510(k) K093362

2008 HEMODIALYSIS SORBENT SYSTEM by Renal Solutions, Inc. — Product Code FKT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 13, 2010
Date Received
October 28, 2009
Clearance Type
Abbreviated
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 Renal Solutions, Inc.

  • K123835 — 2008 HEMODIALYSIS SORBENT SYSTEM (February 15, 2013)
  • K121497 — VENOFER PUMP (August 17, 2012)
  • K103564 — VENOFER PUMP (February 10, 2011)
  • K093964 — VENOFER PUMP (July 9, 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)

Other clearances for product code FKT

  • K123835 — 2008 HEMODIALYSIS SORBENT SYSTEM (February 15, 2013)
  • 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)
  • K954623 — REDY 2000 SYSTEM (THERAPEUTIC PLASMA EXCHANGE OPTION AND MONITORING LINE Y-CONNE (August 28, 1996)
  • 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)