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510(k) K864113

CLYDE (TM) FILTRATION SYSTEM by Arbor Technologies, Inc. — Product Code FPB

K864113 is an FDA 510(k) premarket notification submitted by Arbor Technologies, Inc. for the device "CLYDE (TM) FILTRATION SYSTEM". The FDA issued a decision of Substantially Equivalent on February 4, 1987. The device falls under product code FPB (Filter, Infusion Line), a Class II device regulated under 21 CFR 880.5440. Arbor Technologies, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 1987
Date Received
October 21, 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 Arbor Technologies, Inc.

  • K960928 — SYRINGEFILTER (April 4, 1997)
  • K964283 — AUTOPRIME (January 22, 1997)
  • K922777 — PRESSURE TUBING AND ACCESSORIES (March 22, 1994)
  • K902666 — ANESTHESIA CONDUCTION FILTER (April 23, 1991)
  • K895859 — CONTAIN(TM) (February 7, 1991)
  • K902167 — CONTAIN(TM) LASER PLUME FILTER (January 4, 1991)
  • K890844 — MICROSEPT 60/20 (June 7, 1989)
  • K874505 — CONTAIN(TM) (May 20, 1988)
  • K863162 — VACU-GUARD (August 29, 1986)

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