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)

INFUMIX MIXING CONTAINER

K-Number: K870052 · 1987-02-27

ApplicantBiodynamics Corp.
Decision Date1987-02-27
Product CodeKPE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

INFUMIX MIXING CONTAINER is the device name listed in this FDA 510(k) record. The listed applicant is Biodynamics Corp.. It received FDA 510(k) clearance on 1987-02-27 under 510(k) number K870052. The device is classified under product code KPE. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INFUMIX MIXING CONTAINER?

INFUMIX MIXING CONTAINER is a medical device that received FDA 510(k) clearance on 1987-02-27. The listed applicant is Biodynamics Corp.. The 510(k) number is K870052.

When did INFUMIX MIXING CONTAINER receive FDA 510(k) clearance?

INFUMIX MIXING CONTAINER received FDA 510(k) clearance on 1987-02-27, under 510(k) number K870052.

Who is the listed applicant for INFUMIX MIXING CONTAINER?

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

What is the FDA product code for INFUMIX MIXING CONTAINER?

The FDA product code for INFUMIX MIXING CONTAINER is KPE.

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 Biodynamics Corp. 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.

K051675BIODYNAMICS BIA 500 BIOMPEDANCE BODY COMPOSITION ANALYZERK884033BIODYNAMICS MODEL 200 BODY COMPOSITION ANALYZERK881631BIODYNAMICS AUTOTRANSFUSION RESERVOIRK881968BIODYNAMICS MODEL BI-400 BODY COMPOSITION ANALYZERK874361BIODYNAMICS MODEL BI-300 BODY COMPOSITION ANALYZERK873807AUTOTRANSFUSION APPARATUS

View all 21 devices →

Related Devices (Code: KPE)

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.

K252079Disposable Infusion Bag for Parenteral NutritionBeijing L&Z Medical Technology Development Co., Ltd.K251980ClaveQS™ BagIcu Medical, Inc.K251139KabiHelp® Uno; KabiHelp® Advance plusFresenius Kabi AGK252094eZSURE™ Empty Fluid ContainerEpic Medical Pte. , Ltd.K250459DMRX 100ml Empty Container Solution; DMRX 250ml Empty Container Solution; DMRX 500ml Empty Container Solution; DMRX 1000ml Empty Container SolutionTechnoflex Sas.K241442eZSURE™ Empty Fluid Container with ProSeal™ Injection SiteEpic Medical Pte. , Ltd.

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.

↑