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510(k) K022477

SUMMIT MEDICAL LTD TRANSFUSION FILTER, MODEL LF400 & SUMMIT MEDICAL LTD TRANSFUSION FILTER WITH ADMINISTRATION SET by Summit Medical , Ltd. — Product Code CAK

K022477 is an FDA 510(k) premarket notification submitted by Summit Medical , Ltd. for the device "SUMMIT MEDICAL LTD TRANSFUSION FILTER, MODEL LF400 & SUMMIT MEDICAL LTD TRANSFUSION FILTER WITH ADMINISTRATION SET". The FDA issued a decision of Substantially Equivalent on October 25, 2002. The device falls under product code CAK (Microfilter, Blood Transfusion), a Class II device regulated under 21 CFR 880.5440. Summit Medical , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 25, 2002
Date Received
July 29, 2002
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 Summit Medical , Ltd.

  • K180528 — InstruSafe(R) Sterilization Container (November 16, 2018)
  • K173110 — GRAFTSITE (May 18, 2018)
  • K170388 — ANCHORMAN Tibial Ligament Fixation Device (July 25, 2017)
  • K162046 — MINNE TIES MMF Suture System (April 11, 2017)
  • K151166 — Instru-Safe Instrument Protection System (August 18, 2015)
  • K150540 — Instru-Safe Instrument Protection System (June 22, 2015)
  • K142768 — Instru-Safe Instrument Protection System (May 29, 2015)
  • K142630 — Instru-Safe Instrument Protection System (December 23, 2014)
  • K141513 — INSTRU-SAFE INSTRUMENT PROTECTION SYSTEM (December 15, 2014)
  • K140289 — INSTRU-SAFE INSTRUMENT PROTECTION SYSTEM (June 27, 2014)

Other clearances for product code CAK

  • K061103 — HAEMONETICS 40U RBC FILTER BAG (May 17, 2006)
  • 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)
  • K904223 — SEPACELL(R) R-200/500 LEUKOCYTE REMOVAL RECIP SETS (October 26, 1990)

FDA data resources