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FDA 510(k)

AMSafe NeuFlo Needleless Connector

K-Number: K220267 · 2022-10-07

ApplicantAmsino International, Inc.
Decision Date2022-10-07
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

AMSafe NeuFlo Needleless 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 2022-10-07 under 510(k) number K220267. 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 NeuFlo Needleless Connector?

AMSafe NeuFlo Needleless Connector is a medical device that received FDA 510(k) clearance on 2022-10-07. The listed applicant is Amsino International, Inc.. The 510(k) number is K220267.

When did AMSafe NeuFlo Needleless Connector receive FDA 510(k) clearance?

AMSafe NeuFlo Needleless Connector received FDA 510(k) clearance on 2022-10-07, under 510(k) number K220267.

Who is the listed applicant for AMSafe NeuFlo Needleless 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 NeuFlo Needleless Connector?

The FDA product code for AMSafe NeuFlo Needleless Connector is FPA.

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 PumpK213522AMSafe Pre-Filled Normal Saline Flush SyringeK200051PUGGLE Enteral Feeding Pump and Feeding SetK183473AMSafe(R) Pre-Filled Normal Saline Flush SyringeK181445AMSure Hydrophilic Intermittent Catheter

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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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