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510(k) K851816

SARTORIUS MINISART FH 16534 by Sartorius Filters, Inc. — Product Code FPB

K851816 is an FDA 510(k) premarket notification submitted by Sartorius Filters, Inc. for the device "SARTORIUS MINISART FH 16534". The FDA issued a decision of Substantially Equivalent on August 19, 1985. The device falls under product code FPB (Filter, Infusion Line), a Class II device regulated under 21 CFR 880.5440. Sartorius Filters, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 19, 1985
Date Received
April 26, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Filter, Infusion Line
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

Other clearances by Sartorius Filters, Inc.

  • K851818 — SARTORIUS MINI SART FH 16592 (August 19, 1985)
  • K851817 — SARTORIUS MINI-SART FH 16555 (August 19, 1985)
  • K850435 — SARTORIUS AQUASART SM 40035 - DIALYSATE SYS (June 4, 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 FPB

  • K233277 — Filter Needle for Single Use (May 10, 2024)
  • K143583 — Cathivex ¿GV filter units (August 11, 2015)
  • K113227 — NON-DEHP MICRO-VOLUME EXTENSION SET WITH 0.22 MICRON FILTER (December 8, 2011)
  • K021293 — ARTERIA BLOOD FILTER (August 22, 2002)
  • K993379 — PALL SUPOR AEF FILTER (December 16, 1999)
  • K974661 — 0.2 U BACTERIAL FILTER (February 11, 1998)
  • K964283 — AUTOPRIME (January 22, 1997)
  • K954331 — PALL LEA FILTER (LIPID EMULSION FILTER) (I.V. FILTER) (January 9, 1997)
  • K933523 — I.V. FILTER SET (May 19, 1995)
  • K941628 — 40 MICRON BLOOD TRANSFUSION FILTER (February 16, 1995)

FDA data resources