Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Sapphire II PRO

K-Number: K163114 · 2017-01-05

ApplicantOrbusneich Medical, Inc.
Decision Date2017-01-05
Product CodeLOX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Sapphire II PRO is a medical device manufactured by Orbusneich Medical, Inc.. It received FDA 510(k) clearance on 2017-01-05 under approval number K163114. 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 II PRO?

Sapphire II PRO is a medical device that received FDA 510(k) clearance on 2017-01-05. It is manufactured by Orbusneich Medical, Inc.. The 510(k) number is K163114.

When was Sapphire II PRO approved by the FDA?

Sapphire II PRO received FDA 510(k) clearance on 2017-01-05, under approval number K163114.

What company makes Sapphire II PRO?

Sapphire II PRO is manufactured by Orbusneich Medical, Inc..

What is the FDA product code for Sapphire II PRO?

The FDA product code for Sapphire II PRO is LOX.

Other Devices by Orbusneich Medical, Inc.

K162209Sapphire NC Plus

Related Devices (Code: LOX)

K163200Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation CatheteBoston Scientific Corporation K163174Emerge PTCA Dilatation CatheterBoston Scientific Corporation K160985Pantera ProBiotronik, Inc. K162209Sapphire NC PlusOrbusneich Medical, Inc. K153742Apollo Balloon Dilatation CatheterBrosmed Medical Co., Ltd. K160961Mozec NC-Rx PTCA Baloon Dilatation CatheterMeril Life Sciences Private Limited

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.

↑