PENTATRASFU BLOOD TRANSFUSION SETS— 510(k) K041496

Name: FDA 510(k) clearance K041496
Creator: U.S. Food and Drug Administration
Published: 2005-06-30

Substantially Equivalent

Pentaferte S.P.A

FDA 510(k) clearance K041496 for PENTATRASFU BLOOD TRANSFUSION SETS, Substantially Equivalent on 2005-06-30. Applicant: Pentaferte S.P.A. Device class: 2.

Clearance details

Applicant: Pentaferte S.P.A
Product code: Code BRZ
Device class: Class 2
Regulation: 21 CFR 880.5440
Advisory panel: General Hospital
Date received: 2004-06-04
Decision date: 2005-06-30
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Parkland, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code BRZ

view all

K220558 — Blood Administration Sets2022-11-17
K210335 — Blood Administration Set2021-06-10
K132905 — 200 MICRON BLOOD COMPONENT FILTER AND SYRINGE ADAPTER2013-10-04
K083349 — BLOOD TRANSFUSION SET2009-04-10
K073339 — BLOOD COMPONENT RECIPIENT SET WITH STANDARD SIZE FILTER AND INFUSION SET WITH SIDE ARM LUER CONNECTOR2008-03-03

More clearances from Pentaferte S.P.A

view all

K041495 — PENTADEFLUE IV SOLUTION ADMINISTRATION SETS2005-04-15

Adverse events under product code BRZ

product code BRZ

Malfunction: 458
Total: 458

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.