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510(k) K864441

CHURCHILL BLOOD ADMINISTRATION SET by Churchill Corp. — Product Code BRZ

K864441 is an FDA 510(k) premarket notification submitted by Churchill Corp. for the device "CHURCHILL BLOOD ADMINISTRATION SET". The FDA issued a decision of Substantially Equivalent on January 20, 1987. The device falls under product code BRZ (Set, Blood Transfusion), a Class II device regulated under 21 CFR 880.5440. Churchill Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 20, 1987
Date Received
November 12, 1986
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 Churchill Corp.

  • K880051 — ENTERAL BAG/SET (April 14, 1988)
  • K880025 — CHURCHILL 0.22 MICRON LIQUID FILTER SETS (April 14, 1988)
  • K880026 — CHURCHILL 0.22 MICRON LIQUID COMPACT FILTER SETS (April 14, 1988)
  • K880027 — CHURCHILL 1.2 MICRON LIQUID FILTER SET (April 13, 1988)
  • K870395 — CHURCHILL PARENTERAL NUTRITION BAG - EVA (October 15, 1987)
  • K872585 — CHURCHILL-CATH (October 15, 1987)
  • K872124 — CHURCHILL ALBUMIN IV ADMINISTRATION SET (October 13, 1987)
  • K872123 — CHURCHILL TPN ADMINISTRATION SET (October 9, 1987)
  • K872043 — CHURCHILL INTER-CARDIAC SUCKER (September 30, 1987)
  • K871084 — NITROGLYCERINE PUMP SET (July 16, 1987)

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