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FDA 510(k)

AMSafe Sure-Lok Needle-Free Connector

K-Number: K173665 · 2018-09-05

ApplicantAmsino International, Inc.
Decision Date2018-09-05
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

AMSafe Sure-Lok Needle-Free Connector is the device name listed in this FDA 510(k) record. The listed applicant is Amsino International, Inc.. It received FDA 510(k) clearance on 2018-09-05 under 510(k) number K173665. 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 AMSafe Sure-Lok Needle-Free Connector?

AMSafe Sure-Lok Needle-Free Connector is a medical device that received FDA 510(k) clearance on 2018-09-05. The listed applicant is Amsino International, Inc.. The 510(k) number is K173665.

When did AMSafe Sure-Lok Needle-Free Connector receive FDA 510(k) clearance?

AMSafe Sure-Lok Needle-Free Connector received FDA 510(k) clearance on 2018-09-05, under 510(k) number K173665.

Who is the listed applicant for AMSafe Sure-Lok Needle-Free Connector?

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

What is the FDA product code for AMSafe Sure-Lok Needle-Free Connector?

The FDA product code for AMSafe Sure-Lok Needle-Free Connector 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.

NCT07519304Effectiveness of a Needle-free Connector With Anti-reflux Technology in Reducing Complications From Long Peripheral Venous Catheters in Hospitalised Adult Patients: Randomised Clinical TrialNOT_YET_RECRUITING

Other records listing Amsino International, 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.

K252543AMSafe 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)K220230AMSure Enteral Feeding PumpK220267AMSafe NeuFlo Needleless ConnectorK213522AMSafe Pre-Filled Normal Saline Flush SyringeK200051PUGGLE Enteral Feeding Pump and Feeding SetK183473AMSafe(R) Pre-Filled Normal Saline Flush Syringe

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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.

K261530iiSure 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)K251814EZ™ IV Administration SetEpic 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.

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