Home / 510(k) Clearances / K964283

510(k) K964283

AUTOPRIME by Arbor Technologies, Inc. — Product Code FPB

K964283 is an FDA 510(k) premarket notification submitted by Arbor Technologies, Inc. for the device "AUTOPRIME". The FDA issued a decision of Substantially Equivalent on January 22, 1997. 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
January 22, 1997
Date Received
October 28, 1996
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)
  • 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 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)
  • 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)
  • K942625 — 1.2 MICRON AIR ELIMINATING FILTER (October 7, 1994)

FDA data resources