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)

Y-TYPE BLOOD ADMINISTRATION SET MODEL #HT-TR2

K-Number: K921595 · 1992-12-24

ApplicantHaemotronic, Inc.
Decision Date1992-12-24
Product CodeBRZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Y-TYPE BLOOD ADMINISTRATION SET MODEL #HT-TR2 is the device name listed in this FDA 510(k) record. The listed applicant is Haemotronic, Inc.. It received FDA 510(k) clearance on 1992-12-24 under 510(k) number K921595. 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 Y-TYPE BLOOD ADMINISTRATION SET MODEL #HT-TR2?

Y-TYPE BLOOD ADMINISTRATION SET MODEL #HT-TR2 is a medical device that received FDA 510(k) clearance on 1992-12-24. The listed applicant is Haemotronic, Inc.. The 510(k) number is K921595.

When did Y-TYPE BLOOD ADMINISTRATION SET MODEL #HT-TR2 receive FDA 510(k) clearance?

Y-TYPE BLOOD ADMINISTRATION SET MODEL #HT-TR2 received FDA 510(k) clearance on 1992-12-24, under 510(k) number K921595.

Who is the listed applicant for Y-TYPE BLOOD ADMINISTRATION SET MODEL #HT-TR2?

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

What is the FDA product code for Y-TYPE BLOOD ADMINISTRATION SET MODEL #HT-TR2?

The FDA product code for Y-TYPE BLOOD ADMINISTRATION SET MODEL #HT-TR2 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 Haemotronic, 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.

K921597CAVH/CVVH/CAVHD SET MODEL #HT-HF/505K921594HAEMOTROL MODEL #HT-SB/6 BURETTE SETK913361DRAIN/PRIMING/RECIRCULATION BAG

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.

↑