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FDA 510(k)

STERI-SPOUTS; BAG-SPOUT, VIAL-SPOUT, TRANSFER MIXER; RAPIDFLOW, VIALFLOW, TRANSFLOW

K-Number: K023539 · 2002-12-17

ApplicantValumed
Decision Date2002-12-17
Product CodeLHI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

STERI-SPOUTS; BAG-SPOUT, VIAL-SPOUT, TRANSFER MIXER; RAPIDFLOW, VIALFLOW, TRANSFLOW is the device name listed in this FDA 510(k) record. The listed applicant is Valumed. It received FDA 510(k) clearance on 2002-12-17 under 510(k) number K023539. 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 STERI-SPOUTS; BAG-SPOUT, VIAL-SPOUT, TRANSFER MIXER; RAPIDFLOW, VIALFLOW, TRANSFLOW?

STERI-SPOUTS; BAG-SPOUT, VIAL-SPOUT, TRANSFER MIXER; RAPIDFLOW, VIALFLOW, TRANSFLOW is a medical device that received FDA 510(k) clearance on 2002-12-17. The listed applicant is Valumed. The 510(k) number is K023539.

When did STERI-SPOUTS; BAG-SPOUT, VIAL-SPOUT, TRANSFER MIXER; RAPIDFLOW, VIALFLOW, TRANSFLOW receive FDA 510(k) clearance?

STERI-SPOUTS; BAG-SPOUT, VIAL-SPOUT, TRANSFER MIXER; RAPIDFLOW, VIALFLOW, TRANSFLOW received FDA 510(k) clearance on 2002-12-17, under 510(k) number K023539.

Who is the listed applicant for STERI-SPOUTS; BAG-SPOUT, VIAL-SPOUT, TRANSFER MIXER; RAPIDFLOW, VIALFLOW, TRANSFLOW?

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

What is the FDA product code for STERI-SPOUTS; BAG-SPOUT, VIAL-SPOUT, TRANSFER MIXER; RAPIDFLOW, VIALFLOW, TRANSFLOW?

The FDA product code for STERI-SPOUTS; BAG-SPOUT, VIAL-SPOUT, TRANSFER MIXER; RAPIDFLOW, VIALFLOW, TRANSFLOW 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 Valumed 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.

K023540SNAP KOVER, MODEL 01-2020; SNAP KAPS, MODEL 03-KP09

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

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

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