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FDA 510(k)

INFUSION SETS

K-Number: K103344 · 2010-12-10

ApplicantHospira, Inc.
Decision Date2010-12-10
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

INFUSION SETS is the device name listed in this FDA 510(k) record. The listed applicant is Hospira, Inc.. It received FDA 510(k) clearance on 2010-12-10 under 510(k) number K103344. 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 INFUSION SETS?

INFUSION SETS is a medical device that received FDA 510(k) clearance on 2010-12-10. The listed applicant is Hospira, Inc.. The 510(k) number is K103344.

When did INFUSION SETS receive FDA 510(k) clearance?

INFUSION SETS received FDA 510(k) clearance on 2010-12-10, under 510(k) number K103344.

Who is the listed applicant for INFUSION SETS?

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

What is the FDA product code for INFUSION SETS?

The FDA product code for INFUSION SETS is FPA.

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Other records listing Hospira, 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.

K161469Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play ModuleK161036Hospira Extension Set, Hospira Primary SetK160492Hospira Sapphire SetsK160870Hospira Administration SetsK143612LifeCare PCA Infusion SystemK132276STERILE EMPTY GLASS CONTAINER, 250ML, STERILE EMPTY GLASS CONTAINER, 500 ML, STERILE EMPTY GLASS CONTAINER, 1000 ML

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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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