FDA 510(k)

Sapphire Sets

K-Number: K171346 · 2017-08-25

Decision Date2017-08-25

Product CodeMRZ

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Sapphire Sets is a medical device manufactured by Icu Medical. It received FDA 510(k) clearance on 2017-08-25 under approval number K171346. 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 Sapphire Sets?

Sapphire Sets is a medical device that received FDA 510(k) clearance on 2017-08-25. It is manufactured by Icu Medical. The 510(k) number is K171346.

When was Sapphire Sets approved by the FDA?

Sapphire Sets received FDA 510(k) clearance on 2017-08-25, under approval number K171346.

What company makes Sapphire Sets?

Sapphire Sets is manufactured by Icu Medical.

What is the FDA product code for Sapphire Sets?

The FDA product code for Sapphire Sets is MRZ.

Other Devices by Icu Medical

K190157Diana ChemoClave Transfer Set K192154Rio Vial-to-Bag Drug Reconstitution Device K190918SwabTip Male Disinfectant Cap K232048Cogent Hemodynamic Monitoring System; Cogent HMS

Related Devices (Code: MRZ)

K160492Hospira Sapphire SetsHospira, Inc. K162225WellDoc BlueStar (WellDoc DiabetesManager System and DiabetesManager-Rx SystemWelldoc, Inc. 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.