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510(k) K990310

CHARTER MEDICAL, LTD MP 450 (40 MICRON FILTER) by Charter Medical, Ltd. — Product Code CAK

K990310 is an FDA 510(k) premarket notification submitted by Charter Medical, Ltd. for the device "CHARTER MEDICAL, LTD MP 450 (40 MICRON FILTER)". The FDA issued a decision of Substantially Equivalent on August 30, 1999. The device falls under product code CAK (Microfilter, Blood Transfusion), a Class II device regulated under 21 CFR 880.5440. Charter Medical, Ltd. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 30, 1999
Date Received
February 1, 1999
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 Charter Medical, Ltd.

  • K000685 — CHARTER MEDICAL NEONATAL SYRINGE SET (August 15, 2000)

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)
  • 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)
  • 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)

FDA data resources