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510(k) K960928

SYRINGEFILTER by Arbor Technologies, Inc. — Product Code BSN

K960928 is an FDA 510(k) premarket notification submitted by Arbor Technologies, Inc. for the device "SYRINGEFILTER". The FDA issued a decision of Substantially Equivalent on April 4, 1997. The device falls under product code BSN (Filter, Conduction, Anesthetic), a Class II device regulated under 21 CFR 868.5130. Arbor Technologies, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 4, 1997
Date Received
March 7, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Filter, Conduction, Anesthetic
Device Class
Class II
Regulation Number
868.5130
Review Panel
AN
Submission Type

Other clearances by Arbor Technologies, Inc.

  • 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)
  • K864113 — CLYDE (TM) FILTRATION SYSTEM (February 4, 1987)
  • K863162 — VACU-GUARD (August 29, 1986)

Other clearances for product code BSN

  • K190663 — Epidural MiniFilter LUER 80369-7, Epidural MiniFilter NRFit 80369-6 (June 17, 2019)
  • K133004 — VENTED MILLEX -GV, CATHIVEX -GV (March 27, 2014)
  • K083451 — PORTEX EPIDURAL FILTER, MODEL 100/386/010, VARIOUS STANDARD AND CUSTOM TRAYS (March 4, 2009)
  • K023892 — MILLEX VV, GV, AND HV SYRINGE FILTER UNITS (January 17, 2003)
  • K013988 — MILLEX GP STERILIZING FILTER UNIT, MODEL SLGP 033 R (April 4, 2002)
  • K963717 — MILLEX - MP FILTER UNIT (SLMPO25SS/SLMPL25SS) (June 10, 1997)
  • K902666 — ANESTHESIA CONDUCTION FILTER (April 23, 1991)
  • K780519 — FILTER TUBE (May 9, 1978)

FDA data resources