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FDA 510(k)

Hospira Extension Set, Hospira Primary Set

K-Number: K161036 · 2017-01-06

ApplicantHospira, Inc.
Decision Date2017-01-06
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Hospira Extension Set, Hospira Primary Set is the device name listed in this FDA 510(k) record. The listed applicant is Hospira, Inc.. It received FDA 510(k) clearance on 2017-01-06 under 510(k) number K161036. 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 Hospira Extension Set, Hospira Primary Set?

Hospira Extension Set, Hospira Primary Set is a medical device that received FDA 510(k) clearance on 2017-01-06. The listed applicant is Hospira, Inc.. The 510(k) number is K161036.

When did Hospira Extension Set, Hospira Primary Set receive FDA 510(k) clearance?

Hospira Extension Set, Hospira Primary Set received FDA 510(k) clearance on 2017-01-06, under 510(k) number K161036.

Who is the listed applicant for Hospira Extension Set, Hospira Primary Set?

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 Hospira Extension Set, Hospira Primary Set?

The FDA product code for Hospira Extension Set, Hospira Primary Set is FPA.

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 ModuleK160492Hospira Sapphire SetsK160870Hospira Administration SetsK143612LifeCare PCA Infusion System

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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