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FDA 510(k)

BLOOD & PLASMA ADMIN. DEV-STERILE

K-Number: K840411 · 1984-03-19

ApplicantLoversan
Decision Date1984-03-19
Product CodeBRZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BLOOD & PLASMA ADMIN. DEV-STERILE is the device name listed in this FDA 510(k) record. The listed applicant is Loversan. It received FDA 510(k) clearance on 1984-03-19 under 510(k) number K840411. 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 & PLASMA ADMIN. DEV-STERILE?

BLOOD & PLASMA ADMIN. DEV-STERILE is a medical device that received FDA 510(k) clearance on 1984-03-19. The listed applicant is Loversan. The 510(k) number is K840411.

When did BLOOD & PLASMA ADMIN. DEV-STERILE receive FDA 510(k) clearance?

BLOOD & PLASMA ADMIN. DEV-STERILE received FDA 510(k) clearance on 1984-03-19, under 510(k) number K840411.

Who is the listed applicant for BLOOD & PLASMA ADMIN. DEV-STERILE?

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

What is the FDA product code for BLOOD & PLASMA ADMIN. DEV-STERILE?

The FDA product code for BLOOD & PLASMA ADMIN. DEV-STERILE 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 Loversan 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.

K840409INFUSION SET-STERILEK840410SOLUTION ADMIN. SET STERILE

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.

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