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FDA 510(k)

BLOOD TRANSFUSION SET

K-Number: K083349 · 2009-04-10

ApplicantShan Dong Wei Gao Group Medical Polymer Products
Decision Date2009-04-10
Product CodeBRZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BLOOD TRANSFUSION SET is the device name listed in this FDA 510(k) record. The listed applicant is Shan Dong Wei Gao Group Medical Polymer Products. It received FDA 510(k) clearance on 2009-04-10 under 510(k) number K083349. 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 TRANSFUSION SET?

BLOOD TRANSFUSION SET is a medical device that received FDA 510(k) clearance on 2009-04-10. The listed applicant is Shan Dong Wei Gao Group Medical Polymer Products. The 510(k) number is K083349.

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

BLOOD TRANSFUSION SET received FDA 510(k) clearance on 2009-04-10, under 510(k) number K083349.

Who is the listed applicant for BLOOD TRANSFUSION SET?

The FDA 510(k) record lists Shan Dong Wei Gao Group Medical Polymer Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BLOOD TRANSFUSION SET?

The FDA product code for BLOOD TRANSFUSION SET is BRZ.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Shan Dong Wei Gao Group Medical Polymer Products 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.

K090459DISPOSABLE TPE INFUSION SETK090012DISPOSABLE INFUSION SET

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.K073339BLOOD COMPONENT RECIPIENT SET WITH STANDARD SIZE FILTER AND INFUSION SET WITH SIDE ARM LUER CONNECTORFenwal, Inc.K041496PENTATRASFU BLOOD TRANSFUSION SETSPentaferte S.P.AK05080530 ML OR 60 ML PEDI-SYRINGE FILTERBlood Products Specialties, LLC

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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