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510(k) K955515

ALPHA MICRON 20 MICROAGGREGATE FILTER by Alpha Therapeutic Corp. — Product Code CAK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 1996
Date Received
December 4, 1995
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 Alpha Therapeutic Corp.

  • K970225 — ALPHA MICRON 20/40 MICROAGGREGATE FILTER (February 14, 1997)
  • K854920 — THERAPY CASSETTS (May 19, 1986)
  • K854441 — STUART GILMAN'S WEIGHT LOSS PLAN (February 10, 1986)
  • K833294 — ALPHA Y-RECIPIENT SET (December 27, 1983)
  • K820447 — ALPHA PLASMA TRANSFER SET (April 14, 1982)
  • K810897 — ALPHA PLASTIC PLASMA BOTTLE (September 23, 1981)
  • K810761 — ALPHA MICRON-40 FILTER (June 30, 1981)

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)
  • K904223 — SEPACELL(R) R-200/500 LEUKOCYTE REMOVAL RECIP SETS (October 26, 1990)
  • K904221 — SEPACELL(R) PL-5A/10A LEUKOCYTE REMOVAL FILTERS (October 26, 1990)