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510(k) K861523

STANDARD BLOOD TRANSFUSION FILTER SET (CODE 1025) by Jufrey Multimed Corp. — Product Code BRZ

K861523 is an FDA 510(k) premarket notification submitted by Jufrey Multimed Corp. for the device "STANDARD BLOOD TRANSFUSION FILTER SET (CODE 1025)". The FDA issued a decision of Substantially Equivalent on May 27, 1986. The device falls under product code BRZ (Set, Blood Transfusion), a Class II device regulated under 21 CFR 880.5440. Jufrey Multimed Corp. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 27, 1986
Date Received
April 23, 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 Jufrey Multimed Corp.

  • K861519 — UNIVERSAL DISPOSABLE INFUSION SET (CODE 0330F) (May 27, 1986)
  • K861518 — UNIVERSAL DISPOSABLE INFUSION SET (CODE 0205F) (May 27, 1986)
  • K861521 — UNIVERSAL DISPOSABLE INFUSION SET (CODE 0330) (May 27, 1986)
  • K861520 — UNIVERSAL DISPOSABLE INFUSION SET (CODE 0205) (May 27, 1986)
  • K853527 — JUFREY CORP. UNIV. DISPOS. SCALP VEIN INFUSION SET (September 23, 1985)
  • K853327 — JUFREY CORP. UNIVERSAL DISPOS. SCALP VEIN INFUSION (August 21, 1985)

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