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510(k) K864179

BIOLOGIC 1000 HEMODIALYSIS MACH/HD-1000 DISP CARTR by Ash Medical Systems, Inc. — Product Code FKT

K864179 is an FDA 510(k) premarket notification submitted by Ash Medical Systems, Inc. for the device "BIOLOGIC 1000 HEMODIALYSIS MACH/HD-1000 DISP CARTR". The FDA issued a decision of Substantially Equivalent on December 11, 1986. The device falls under product code FKT (System, Dialysate Delivery, Sorbent Regenerated), a Class II device regulated under 21 CFR 876.5600. Ash Medical Systems, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 11, 1986
Date Received
October 24, 1986
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 Ash Medical Systems, Inc.

  • K874137 — MODIFIED BIOLOGIC 1000 HEMODIAL. & HD-1000 DIS CAR (April 8, 1988)
  • K870270 — MODIFIED BIO. HEMODIALYSIS & HD-1000 DISP. CART. (February 25, 1987)

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)
  • 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)

FDA data resources