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FDA 510(k)

Sapphire II PRO Balloon Dilatation Catheter

K-Number: K180921 · 2018-06-28

ApplicantOrbusneich Medical Trading, Inc.
Decision Date2018-06-28
Product CodeLOX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Sapphire II PRO Balloon Dilatation Catheter is a medical device manufactured by Orbusneich Medical Trading, Inc.. It received FDA 510(k) clearance on 2018-06-28 under approval number K180921. 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 Balloon Dilatation Catheter?

Sapphire II PRO Balloon Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2018-06-28. It is manufactured by Orbusneich Medical Trading, Inc.. The 510(k) number is K180921.

When was Sapphire II PRO Balloon Dilatation Catheter approved by the FDA?

Sapphire II PRO Balloon Dilatation Catheter received FDA 510(k) clearance on 2018-06-28, under approval number K180921.

What company makes Sapphire II PRO Balloon Dilatation Catheter?

Sapphire II PRO Balloon Dilatation Catheter is manufactured by Orbusneich Medical Trading, Inc..

What is the FDA product code for Sapphire II PRO Balloon Dilatation Catheter?

The FDA product code for Sapphire II PRO Balloon Dilatation Catheter is LOX.

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Other Devices by Orbusneich Medical Trading, Inc.

K182360Teleport Microcatheter K173680Sapphire II PRO K173894Jade PTA Balloon Dilatation Catheter K192344Sapphire NC Plus Coronary Dilatation Catheter K182713Scoreflex PTA Scoring Balloon Catheter K200269Sapphire II PRO

View all 7 devices →

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.

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