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510(k) K050805

30 ML OR 60 ML PEDI-SYRINGE FILTER by Blood Products Specialties, LLC — Product Code BRZ

K050805 is an FDA 510(k) premarket notification submitted by Blood Products Specialties, LLC for the device "30 ML OR 60 ML PEDI-SYRINGE FILTER". The FDA issued a decision of Substantially Equivalent on June 20, 2005. The device falls under product code BRZ (Set, Blood Transfusion), a Class II device regulated under 21 CFR 880.5440.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 2005
Date Received
March 30, 2005
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 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)
  • 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)
  • K993120 — MODIFIED BLOOD RECIPIENT SET (November 17, 1999)

FDA data resources