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510(k) K860803

IV FILTER EXTENSION SET by Med Fusion Systems, Inc. — Product Code FPB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 9, 1986
Date Received
March 4, 1986
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 Med Fusion Systems, Inc.

  • K873961 — INFUMED 300 AMBULATORY INFUSION PUMP (December 29, 1987)
  • K870524 — AMBULATORY INFUSION PUMP DRUG RESERVOIR (May 6, 1987)
  • K870907 — INTRODUCER, PERCUTANEOUS (April 9, 1987)
  • K864407 — REFILLABLE SYRINGE (January 20, 1987)
  • K863814 — BAG SPIKE EXTENSION SET (October 14, 1986)
  • K860616 — VOLUME CONTROL SET WITH EXTENSION (June 2, 1986)
  • K844313 — INFUSET W/HUBER NEEDLE (January 22, 1985)
  • K842984 — EXTENSION SET W/INJECTION SITE (October 16, 1984)
  • K842143 — BENT WINGED MINI-VOL INFUSION SET (July 20, 1984)
  • K841882 — THREE WAY INFUSION SET (June 5, 1984)

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)