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510(k) K972843

PROTOS BLOOD TRANSFUSION SET by Globe Ent., Inc. — Product Code BRZ

K972843 is an FDA 510(k) premarket notification submitted by Globe Ent., Inc. for the device "PROTOS BLOOD TRANSFUSION SET". The FDA issued a decision of Substantially Equivalent on December 16, 1997. The device falls under product code BRZ (Set, Blood Transfusion), a Class II device regulated under 21 CFR 880.5440. Globe Ent., Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 16, 1997
Date Received
August 1, 1997
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 Globe Ent., Inc.

  • K972839 — PROTOS 100ML BURETTE INFUSION SET/ PROTOS 150ML BURETTE INFUSION SET (December 17, 1997)
  • K972854 — PROTOS I.V. ADMINISTRATION SET (15 DROPS/ML) I4070S/(60 DROPS/ML)I4670S PRELIMIN (December 17, 1997)
  • K892623 — PATIENT EXAMINATION GLOVES (LATEX) (September 11, 1989)
  • K884622 — SURGICAL GLOVES (March 14, 1989)

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