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510(k) K921595

Y-TYPE BLOOD ADMINISTRATION SET MODEL #HT-TR2 by Haemotronic, Inc. — Product Code BRZ

K921595 is an FDA 510(k) premarket notification submitted by Haemotronic, Inc. for the device "Y-TYPE BLOOD ADMINISTRATION SET MODEL #HT-TR2". The FDA issued a decision of Substantially Equivalent on December 24, 1992. The device falls under product code BRZ (Set, Blood Transfusion), a Class II device regulated under 21 CFR 880.5440. Haemotronic, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 24, 1992
Date Received
April 3, 1992
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 Haemotronic, Inc.

  • K210749 — Empty EVA Bag (August 19, 2021)
  • K193528 — Empty EVA Bag (July 22, 2020)
  • K921597 — CAVH/CVVH/CAVHD SET MODEL #HT-HF/505 (February 24, 1995)
  • K921594 — HAEMOTROL MODEL #HT-SB/6 BURETTE SET (December 24, 1992)
  • K913361 — DRAIN/PRIMING/RECIRCULATION BAG (March 30, 1992)

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