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510(k) K041496

PENTATRASFU BLOOD TRANSFUSION SETS by Pentaferte S.P.A — Product Code BRZ

K041496 is an FDA 510(k) premarket notification submitted by Pentaferte S.P.A for the device "PENTATRASFU BLOOD TRANSFUSION SETS". The FDA issued a decision of Substantially Equivalent on June 30, 2005. The device falls under product code BRZ (Set, Blood Transfusion), a Class II device regulated under 21 CFR 880.5440. Pentaferte S.P.A has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 30, 2005
Date Received
June 4, 2004
Clearance Type
Abbreviated
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 Pentaferte S.P.A

  • K041495 — PENTADEFLUE IV SOLUTION ADMINISTRATION SETS (April 15, 2005)
  • K002381 — PENTAFERTE SINGLE USE SYRINGES, MODEL SIZE=VARIOUS SIZES (January 11, 2001)

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)
  • 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