FDA 510(k)

Hospira Sapphire Sets

K-Number: K160492 · 2016-12-06

Decision Date2016-12-06

Product CodeMRZ

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Hospira Sapphire Sets is a medical device manufactured by Hospira, Inc.. It received FDA 510(k) clearance on 2016-12-06 under approval number K160492. The device is classified under product code MRZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Hospira Sapphire Sets?

Hospira Sapphire Sets is a medical device that received FDA 510(k) clearance on 2016-12-06. It is manufactured by Hospira, Inc.. The 510(k) number is K160492.

When was Hospira Sapphire Sets approved by the FDA?

Hospira Sapphire Sets received FDA 510(k) clearance on 2016-12-06, under approval number K160492.

What company makes Hospira Sapphire Sets?

Hospira Sapphire Sets is manufactured by Hospira, Inc..

What is the FDA product code for Hospira Sapphire Sets?

The FDA product code for Hospira Sapphire Sets is MRZ.

Other Devices by Hospira, Inc.

K160870Hospira Administration Sets K143612LifeCare PCA Infusion System K161469Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module K161036Hospira Extension Set, Hospira Primary Set

Related Devices (Code: MRZ)

K162225WellDoc BlueStar (WellDoc DiabetesManager System and DiabetesManager-Rx SystemWelldoc, Inc. K171346Sapphire SetsIcu Medical K162532WellDoc BlueStar, WellDoc BlueStar RxWelldoc, Inc. K173531Lockbox for Perfusor Space PCA Infusion PumpB.Braun Medical, Inc. K190013WellDoc BlueStarWelldoc, Inc. K193654BlueStar RxWelldoc, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.