Home / 510(k) Clearances / K890844

510(k) K890844

MICROSEPT 60/20 by Arbor Technologies, Inc. — Product Code CAK

K890844 is an FDA 510(k) premarket notification submitted by Arbor Technologies, Inc. for the device "MICROSEPT 60/20". The FDA issued a decision of Substantially Equivalent on June 7, 1989. The device falls under product code CAK (Microfilter, Blood Transfusion), 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
June 7, 1989
Date Received
February 21, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Microfilter, Blood Transfusion
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)
  • 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 CAK

  • K061103 — HAEMONETICS 40U RBC FILTER BAG (May 17, 2006)
  • K022477 — SUMMIT MEDICAL LTD TRANSFUSION FILTER, MODEL LF400 & SUMMIT MEDICAL LTD TRANSFUS (October 25, 2002)
  • K000719 — NEOCARE 20 MICRON BLOOD FILTER (May 30, 2000)
  • K990310 — CHARTER MEDICAL, LTD MP 450 (40 MICRON FILTER) (August 30, 1999)
  • K982822 — FENWAL 20 MICRON PEDIATRIC TRANSFUSION FILTER MODEL 4C7701, FENWAL 20 MICRON PED (September 30, 1998)
  • K972159 — FENWAL 40 MICRON TRANSFUSION FILTER (July 23, 1997)
  • K970225 — ALPHA MICRON 20/40 MICROAGGREGATE FILTER (February 14, 1997)
  • K960993 — PALL SQ40S BLOOD FILTER (SQ40S/SQ40ST) (April 22, 1996)
  • K955515 — ALPHA MICRON 20 MICROAGGREGATE FILTER (February 12, 1996)
  • K904221 — SEPACELL(R) PL-5A/10A LEUKOCYTE REMOVAL FILTERS (October 26, 1990)

FDA data resources