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FDA 510(k)

AUTOMIX COMPOUNDER VENTED SPIKE ADAPTOR

K-Number: K890204 · 1989-10-27

ApplicantStedim, Inc.
Decision Date1989-10-27
Product CodeLHI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

AUTOMIX COMPOUNDER VENTED SPIKE ADAPTOR is the device name listed in this FDA 510(k) record. The listed applicant is Stedim, Inc.. It received FDA 510(k) clearance on 1989-10-27 under 510(k) number K890204. The device is classified under product code LHI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUTOMIX COMPOUNDER VENTED SPIKE ADAPTOR?

AUTOMIX COMPOUNDER VENTED SPIKE ADAPTOR is a medical device that received FDA 510(k) clearance on 1989-10-27. The listed applicant is Stedim, Inc.. The 510(k) number is K890204.

When did AUTOMIX COMPOUNDER VENTED SPIKE ADAPTOR receive FDA 510(k) clearance?

AUTOMIX COMPOUNDER VENTED SPIKE ADAPTOR received FDA 510(k) clearance on 1989-10-27, under 510(k) number K890204.

Who is the listed applicant for AUTOMIX COMPOUNDER VENTED SPIKE ADAPTOR?

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

What is the FDA product code for AUTOMIX COMPOUNDER VENTED SPIKE ADAPTOR?

The FDA product code for AUTOMIX COMPOUNDER VENTED SPIKE ADAPTOR is LHI.

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 Stedim, 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.

K911567DUAL COMPARTMENT TPN BAG 3 LITERK890205AUTOMIX COMPOUNDER Y - ADAPTOR SET

Related Devices (Code: LHI)

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.

K252987ADRx™ Admixture DeviceEpic Medical Pte. , Ltd.K260301Vial AdapterHangzhou Qiantang Longyue Biotechnology Co., Ltd.K250345Medline Bag DecanterMedline Industries, LPK251715FlowArt® Vial Access Device VentedAsset MedikalK251676Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decanter II, Sterile (2002S); Medline Microtek Vial Decanter, Sterile (2006S); Medline Microtek Transfer Device, Sterile (2008S)Microtek Medical, LLCK243404HyHub™ and HyHub™ Duo Vial Access DevicesTakeda Pharmaceuticals

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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