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510(k) K850435

SARTORIUS AQUASART SM 40035 - DIALYSATE SYS by Sartorius Filters, Inc. — Product Code FKR

K850435 is an FDA 510(k) premarket notification submitted by Sartorius Filters, Inc. for the device "SARTORIUS AQUASART SM 40035 - DIALYSATE SYS". The FDA issued a decision of Substantially Equivalent on June 4, 1985. The device falls under product code FKR (Subsystem, Proportioning), a Class II device regulated under 21 CFR 876.5820. Sartorius Filters, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 4, 1985
Date Received
February 4, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Subsystem, Proportioning
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

Other clearances by Sartorius Filters, Inc.

  • K851816 — SARTORIUS MINISART FH 16534 (August 19, 1985)
  • K851818 — SARTORIUS MINI SART FH 16592 (August 19, 1985)
  • K851817 — SARTORIUS MINI-SART FH 16555 (August 19, 1985)
  • K844504 — SARTORIUS MINISART SM 16596HY (January 18, 1985)
  • K830487 — HEMO-PROCESSING SYSTEM (April 28, 1983)
  • K823132 — SARTOPHOR SYSTEM FOR ELECTROPHORESIS (November 27, 1982)
  • K822285 — CELLULOSE ACETATE MEMBRANE STRIPS (September 21, 1982)

Other clearances for product code FKR

  • K140571 — NXSTAGE PUREFLOW SL (May 15, 2014)
  • K111174 — NXSTAGE PUREFLOW SL (September 19, 2011)
  • K080919 — NXSTAGE PUREFLOW SL (October 15, 2008)
  • K060296 — NXSTAGE DIALYSATE PREPARATION MODULE (March 31, 2006)
  • K043436 — NXSTAGE DIALYSATE PREPARATION MODULE, MODEL NX0269 (March 17, 2005)
  • K850756 — AUTO-D AUTOMATIC DISINFECTION ACCESS/ATTACHMENTS (March 20, 1985)
  • K810605 — CHEMATIC BICARBONATE DIALYSATE SYSTEM (June 16, 1981)
  • K810127 — GAMBRO BICARBONATE MODULE, BCM-10 (February 25, 1981)
  • K802465 — BICARB-O-MATE HEMODIALYSIS SOD. BICARB. (November 12, 1980)
  • K800772 — MOD. DM-357 BICARBONATE RETROFIT KIT (May 14, 1980)

FDA data resources