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FDA 510(k)

AMSINO I.V. ADMINISTRATION AND EXTENSION SETS

K-Number: K101958 · 2010-09-29

ApplicantAmsino International, Inc.
Decision Date2010-09-29
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

AMSINO I.V. ADMINISTRATION AND EXTENSION SETS 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 2010-09-29 under 510(k) number K101958. 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 AMSINO I.V. ADMINISTRATION AND EXTENSION SETS?

AMSINO I.V. ADMINISTRATION AND EXTENSION SETS is a medical device that received FDA 510(k) clearance on 2010-09-29. The listed applicant is Amsino International, Inc.. The 510(k) number is K101958.

When did AMSINO I.V. ADMINISTRATION AND EXTENSION SETS receive FDA 510(k) clearance?

AMSINO I.V. ADMINISTRATION AND EXTENSION SETS received FDA 510(k) clearance on 2010-09-29, under 510(k) number K101958.

Who is the listed applicant for AMSINO I.V. ADMINISTRATION AND EXTENSION SETS?

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 AMSINO I.V. ADMINISTRATION AND EXTENSION SETS?

The FDA product code for AMSINO I.V. ADMINISTRATION AND EXTENSION SETS is FPA.

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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.

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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