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FDA 510(k)

Hospira Sapphire Sets

K-Number: K160492 · 2016-12-06

ApplicantHospira, Inc.
Decision Date2016-12-06
Product CodeMRZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Hospira Sapphire 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 2016-12-06 under 510(k) 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. The listed applicant is Hospira, Inc.. The 510(k) number is K160492.

When did Hospira Sapphire Sets receive FDA 510(k) clearance?

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

Who is the listed applicant for Hospira Sapphire 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 Hospira Sapphire Sets?

The FDA product code for Hospira Sapphire Sets is MRZ.

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 SetK160870Hospira Administration SetsK143612LifeCare PCA Infusion System

Related Devices (Code: MRZ)

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.

K230718UTC 3mL Medication CartridgeGilero, LLCK220695Elite Biomedical Solutions Dose Request CordElite Biomedical SolutionsK201634RG 3ml Medication CartridgeChengdu Shifeng Medical Technology Co., Ltd.K193654BlueStar RxWelldoc, Inc.K191910SpaceStation MRIB. Braun Melsugen AGK190013WellDoc BlueStarWelldoc, 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.

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