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FDA 510(k)

SAPPHIRE

K-Number: K103657 · 2011-08-09

ApplicantOrbusneich Medical, Inc.
Decision Date2011-08-09
Product CodeLOX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SAPPHIRE is the device name listed in this FDA 510(k) record. The listed applicant is Orbusneich Medical, Inc.. It received FDA 510(k) clearance on 2011-08-09 under 510(k) number K103657. The device is classified under product code LOX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SAPPHIRE?

SAPPHIRE is a medical device that received FDA 510(k) clearance on 2011-08-09. The listed applicant is Orbusneich Medical, Inc.. The 510(k) number is K103657.

When did SAPPHIRE receive FDA 510(k) clearance?

SAPPHIRE received FDA 510(k) clearance on 2011-08-09, under 510(k) number K103657.

Who is the listed applicant for SAPPHIRE?

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

What is the FDA product code for SAPPHIRE?

The FDA product code for SAPPHIRE is LOX.

Related Clinical Trials

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.

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Other records listing Orbusneich Medical, 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.

K163114Sapphire II PROK162209Sapphire NC PlusK103808SAPPHIRE NC

Related Devices (Code: LOX)

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.

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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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