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510(k) K851370

INTERFACE TRANSFUSION BLOOD FILTER #35 by Medical, Inc. — Product Code CAK

K851370 is an FDA 510(k) premarket notification submitted by Medical, Inc. for the device "INTERFACE TRANSFUSION BLOOD FILTER #35". The FDA issued a decision of Substantially Equivalent on June 27, 1985. The device falls under product code CAK (Microfilter, Blood Transfusion), a Class II device regulated under 21 CFR 880.5440. Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 27, 1985
Date Received
April 5, 1985
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 Medical, Inc.

  • K082311 — EXSUDEX WOUND DRAINAGE PUMP (October 8, 2008)
  • K926454 — ANESTHESIA RESPIRATORY BREATH CIRCUIT PACKS/COMPON (June 22, 1993)
  • K894839 — OS-1 OCCLUSION SYSTEM - 1 (October 24, 1989)
  • K872001 — MODEL TPC-1A OXYGEN ANALYZER (June 15, 1987)
  • K863806 — MODEL A-1 OXYGEN ANALYZER (October 15, 1986)
  • K862609 — INTERFACE ARTERIAL BLOOD FILTER, MODEL 44 (September 4, 1986)
  • K862591 — INTERFACE ARTERIAL BLOOD FILTER, MODEL 42 (September 4, 1986)
  • K861226 — INTERFACE CRYSTALLOID CARDIOPLEGIC FILTER MODEL 70 (June 2, 1986)
  • K823261 — INTERFACE TRANSFUSION BLOOD FILTER #30 (January 7, 1983)
  • K823259 — INTERFACE CARDIOTOMY BLOOD FILTER #50 (November 24, 1982)

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