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FDA 510(k)

VENTED I.V. SET

K-Number: K965027 · 1997-06-24

ApplicantJms Co., Ltd.
Decision Date1997-06-24
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

VENTED I.V. SET is the device name listed in this FDA 510(k) record. The listed applicant is Jms Co., Ltd.. It received FDA 510(k) clearance on 1997-06-24 under 510(k) number K965027. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VENTED I.V. SET?

VENTED I.V. SET is a medical device that received FDA 510(k) clearance on 1997-06-24. The listed applicant is Jms Co., Ltd.. The 510(k) number is K965027.

When did VENTED I.V. SET receive FDA 510(k) clearance?

VENTED I.V. SET received FDA 510(k) clearance on 1997-06-24, under 510(k) number K965027.

Who is the listed applicant for VENTED I.V. SET?

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

What is the FDA product code for VENTED I.V. SET?

The FDA product code for VENTED I.V. SET is FPA.

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 Jms Co., Ltd. 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.

K002352JMS A.V. FISTULA NEEDLE SET ACCORDION TYPEK002394JMS APHERESIS NEEDLE SET ACCORDION TYPEK010410JMS APHERESIS NEEDLE WING EATER, MODEL 14G-18GK010406JMS A.V. FISTULA NEEDLE SET WING EATER, MODEL 14G-18GK000843MODIFICATION TO JMS APHERESIS NEEDLEK000845MODIFICATION TO JMS A.V. FISTULA NEEDLE SET

View all 24 devices →

Related Devices (Code: FPA)

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.

K254123Ecomed Disposable Administration SetsEcomed Solutions, LLCK261530iiSure Infusion SetDeka Research and DevelopmentK252543AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)Amsino International, Inc.K251375PuraCath Firefly Needleless Connector IT (9005)Puracath Medical, Inc.K251257nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727]Np MedicalK250325BD Alaris Pump Infusion SetCarefusion (Bd)

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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