Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

PROTOS BLOOD TRANSFUSION SET

K-Number: K972843 · 1997-12-16

ApplicantGlobe Ent., Inc.
Decision Date1997-12-16
Product CodeBRZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PROTOS BLOOD TRANSFUSION SET is the device name listed in this FDA 510(k) record. The listed applicant is Globe Ent., Inc.. It received FDA 510(k) clearance on 1997-12-16 under 510(k) number K972843. 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 PROTOS BLOOD TRANSFUSION SET?

PROTOS BLOOD TRANSFUSION SET is a medical device that received FDA 510(k) clearance on 1997-12-16. The listed applicant is Globe Ent., Inc.. The 510(k) number is K972843.

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

PROTOS BLOOD TRANSFUSION SET received FDA 510(k) clearance on 1997-12-16, under 510(k) number K972843.

Who is the listed applicant for PROTOS BLOOD TRANSFUSION SET?

The FDA 510(k) record lists Globe Ent., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PROTOS BLOOD TRANSFUSION SET?

The FDA product code for PROTOS 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 Globe Ent., Inc. 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.

K972854PROTOS I.V. ADMINISTRATION SET (15 DROPS/ML) I4070S/(60 DROPS/ML)I4670S PRELIMINARYK972839PROTOS 100ML BURETTE INFUSION SET/ PROTOS 150ML BURETTE INFUSION SETK892623PATIENT EXAMINATION GLOVES (LATEX)K884622SURGICAL GLOVES

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

View on FDA Database →

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

↑