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FDA 510(k)

Sapphire Infusion Pump

K-Number: K161667 · 2017-03-27

ApplicantQ Core Medical , Ltd.
Decision Date2017-03-27
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Sapphire Infusion Pump is the device name listed in this FDA 510(k) record. The listed applicant is Q Core Medical , Ltd.. It received FDA 510(k) clearance on 2017-03-27 under 510(k) number K161667. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sapphire Infusion Pump?

Sapphire Infusion Pump is a medical device that received FDA 510(k) clearance on 2017-03-27. The listed applicant is Q Core Medical , Ltd.. The 510(k) number is K161667.

When did Sapphire Infusion Pump receive FDA 510(k) clearance?

Sapphire Infusion Pump received FDA 510(k) clearance on 2017-03-27, under 510(k) number K161667.

Who is the listed applicant for Sapphire Infusion Pump?

The FDA 510(k) record lists Q Core Medical , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sapphire Infusion Pump?

The FDA product code for Sapphire Infusion Pump is FRN.

Other records listing Q Core Medical , Ltd. 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.

K192860Sapphire Infusion Pump, Sapphire administration sets

Related Devices (Code: FRN)

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.

K253703RemunityPRO+ Pump for Remodulin® (treprostinil) InjectionDeka R&D CorpK252015FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate TubingKoru Medical Systems, Inc.K251640SIGMA Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare CorporationK251636Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)Baxter Healthcare CorporationK242752MRidium 3870 MRI Infusion Pump System (3870)Iradimed CorporationK243855BD Alaris Infusion System with Guardrails Suite MXCarefusion 303, Inc.

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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