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FDA 510(k)

BLOOD/SOLUTION ADMINISTRATION SET, MODEL 33.015

K-Number: K023039 · 2002-11-07

ApplicantTuta Healthcare Pty Limited
Decision Date2002-11-07
Product CodeBRZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BLOOD/SOLUTION ADMINISTRATION SET, MODEL 33.015 is the device name listed in this FDA 510(k) record. The listed applicant is Tuta Healthcare Pty Limited. It received FDA 510(k) clearance on 2002-11-07 under 510(k) number K023039. 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 BLOOD/SOLUTION ADMINISTRATION SET, MODEL 33.015?

BLOOD/SOLUTION ADMINISTRATION SET, MODEL 33.015 is a medical device that received FDA 510(k) clearance on 2002-11-07. The listed applicant is Tuta Healthcare Pty Limited. The 510(k) number is K023039.

When did BLOOD/SOLUTION ADMINISTRATION SET, MODEL 33.015 receive FDA 510(k) clearance?

BLOOD/SOLUTION ADMINISTRATION SET, MODEL 33.015 received FDA 510(k) clearance on 2002-11-07, under 510(k) number K023039.

Who is the listed applicant for BLOOD/SOLUTION ADMINISTRATION SET, MODEL 33.015?

The FDA 510(k) record lists Tuta Healthcare Pty Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BLOOD/SOLUTION ADMINISTRATION SET, MODEL 33.015?

The FDA product code for BLOOD/SOLUTION ADMINISTRATION SET, MODEL 33.015 is BRZ.

Related Clinical Trials

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Other records listing Tuta Healthcare Pty Limited 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.

K023595BURETTE-IN LINE (150 ML)K020083TUTA HEALTHCARE ARTHROSCOPY FLUSHING SET, MODEL 80.601

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.K041496PENTATRASFU BLOOD TRANSFUSION SETSPentaferte S.P.A

Official Source

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

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