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510(k) K023039

BLOOD/SOLUTION ADMINISTRATION SET, MODEL 33.015 by Tuta Healthcare Pty Limited — Product Code BRZ

K023039 is an FDA 510(k) premarket notification submitted by Tuta Healthcare Pty Limited for the device "BLOOD/SOLUTION ADMINISTRATION SET, MODEL 33.015". The FDA issued a decision of Substantially Equivalent on November 7, 2002. The device falls under product code BRZ (Set, Blood Transfusion), a Class II device regulated under 21 CFR 880.5440. Tuta Healthcare Pty Limited has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 7, 2002
Date Received
September 12, 2002
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 Tuta Healthcare Pty Limited

  • K023595 — BURETTE-IN LINE (150 ML) (December 18, 2002)
  • K020083 — TUTA HEALTHCARE ARTHROSCOPY FLUSHING SET, MODEL 80.601 (February 12, 2002)

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)
  • K000685 — CHARTER MEDICAL NEONATAL SYRINGE SET (August 15, 2000)
  • K993120 — MODIFIED BLOOD RECIPIENT SET (November 17, 1999)

FDA data resources