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510(k) K073339

BLOOD COMPONENT RECIPIENT SET WITH STANDARD SIZE FILTER AND INFUSION SET WITH SIDE ARM LUER CONNECTOR by Fenwal, Inc. — Product Code BRZ

K073339 is an FDA 510(k) premarket notification submitted by Fenwal, Inc. for the device "BLOOD COMPONENT RECIPIENT SET WITH STANDARD SIZE FILTER AND INFUSION SET WITH SIDE ARM LUER CONNECTOR". The FDA issued a decision of Substantially Equivalent on March 3, 2008. The device falls under product code BRZ (Set, Blood Transfusion), a Class II device regulated under 21 CFR 880.5440. Fenwal, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 3, 2008
Date Received
November 28, 2007
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 Fenwal, Inc.

  • K141019 — AMICUS SEPARATOR SYSTEM/ AMICUS SEPERATOR SYSTEM;REFURBISHED (June 10, 2014)
  • K111702 — AMICUS SEPARATOR SYSTEM- USE IN THERAPEUTIC PLASMA EXCHANGE AND FILTER SET FOR A (March 22, 2012)

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)
  • 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)
  • K993120 — MODIFIED BLOOD RECIPIENT SET (November 17, 1999)

FDA data resources