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510(k) K853386

MULTISET 40 by Migada, Ltd. — Product Code BRZ

K853386 is an FDA 510(k) premarket notification submitted by Migada, Ltd. for the device "MULTISET 40". The FDA issued a decision of Substantially Equivalent on August 22, 1985. The device falls under product code BRZ (Set, Blood Transfusion), a Class II device regulated under 21 CFR 880.5440. Migada, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 22, 1985
Date Received
August 12, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Blood Transfusion
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

Other clearances by Migada, Ltd.

  • K954883 — FREE FLOW SAFETY DEVICE (April 23, 1996)
  • K943095 — IV TRANSFER SPIKE (September 30, 1994)
  • K933929 — LAB-SITE(R) SAFETY CANNULA (December 7, 1993)
  • K902881 — LAB-SITE SAFETY NEEDLE (September 26, 1990)
  • K870016 — ARTERIAL BLOOD GASSING MONITORING SYSTEM (ABG) (May 28, 1987)
  • K864453 — EMERGENCY & MILITARY INFUSION SYSTEM (January 20, 1987)
  • K863304 — PRESELECTED FLOW RATE I.V. SET (December 9, 1986)
  • K860952 — I.V. SET WITH AND WITHOUT AIR VENT (August 27, 1986)
  • K861275 — HIGH FLOW I.V. SET (June 2, 1986)
  • K860595 — TRANSFER SET (April 7, 1986)

Other clearances for product code BRZ

  • K220558 — Blood Administration Sets (November 17, 2022)
  • K210335 — Blood Administration Set (June 10, 2021)
  • K132905 — 200 MICRON BLOOD COMPONENT FILTER AND SYRINGE ADAPTER (October 4, 2013)
  • K083349 — BLOOD TRANSFUSION SET (April 10, 2009)
  • K073339 — BLOOD COMPONENT RECIPIENT SET WITH STANDARD SIZE FILTER AND INFUSION SET WITH SI (March 3, 2008)
  • K041496 — PENTATRASFU BLOOD TRANSFUSION SETS (June 30, 2005)
  • K050805 — 30 ML OR 60 ML PEDI-SYRINGE FILTER (June 20, 2005)
  • K050115 — BLOOD HAND PUMP ADMINISTRATION SET (April 1, 2005)
  • K023039 — BLOOD/SOLUTION ADMINISTRATION SET, MODEL 33.015 (November 7, 2002)
  • K000685 — CHARTER MEDICAL NEONATAL SYRINGE SET (August 15, 2000)

FDA data resources