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FDA 510(k)

PENTATRASFU BLOOD TRANSFUSION SETS

K-Number: K041496 · 2005-06-30

ApplicantPentaferte S.P.A
Decision Date2005-06-30
Product CodeBRZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PENTATRASFU BLOOD TRANSFUSION SETS is the device name listed in this FDA 510(k) record. The listed applicant is Pentaferte S.P.A. It received FDA 510(k) clearance on 2005-06-30 under 510(k) number K041496. The device is classified under product code BRZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PENTATRASFU BLOOD TRANSFUSION SETS?

PENTATRASFU BLOOD TRANSFUSION SETS is a medical device that received FDA 510(k) clearance on 2005-06-30. The listed applicant is Pentaferte S.P.A. The 510(k) number is K041496.

When did PENTATRASFU BLOOD TRANSFUSION SETS receive FDA 510(k) clearance?

PENTATRASFU BLOOD TRANSFUSION SETS received FDA 510(k) clearance on 2005-06-30, under 510(k) number K041496.

Who is the listed applicant for PENTATRASFU BLOOD TRANSFUSION SETS?

The FDA 510(k) record lists Pentaferte S.P.A as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PENTATRASFU BLOOD TRANSFUSION SETS?

The FDA product code for PENTATRASFU BLOOD TRANSFUSION SETS is BRZ.

Related Clinical Trials

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Other records listing Pentaferte S.P.A as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K041495PENTADEFLUE IV SOLUTION ADMINISTRATION SETS

Related Devices (Code: BRZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K220558Blood Administration SetsBaxter Healthcare CorporationK210335Blood Administration SetBaxter Healthcare CorporationK132905200 MICRON BLOOD COMPONENT FILTER AND SYRINGE ADAPTERArteriocyte Medical Systems, Inc.K083349BLOOD TRANSFUSION SETShan Dong Wei Gao Group Medical Polymer ProductsK073339BLOOD COMPONENT RECIPIENT SET WITH STANDARD SIZE FILTER AND INFUSION SET WITH SIDE ARM LUER CONNECTORFenwal, Inc.K05080530 ML OR 60 ML PEDI-SYRINGE FILTERBlood Products Specialties, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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