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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 the device name listed in this FDA 510(k) record. The listed applicant is Orbusneich Medical Trading, Inc.. It received FDA 510(k) clearance on 2018-06-28 under 510(k) 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. The listed applicant is Orbusneich Medical Trading, Inc.. The 510(k) number is K180921.

When did Sapphire II PRO Balloon Dilatation Catheter receive FDA 510(k) clearance?

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

Who is the listed applicant for Sapphire II PRO Balloon Dilatation Catheter?

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

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.

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.

NCT05509296Compare the Effectiveness and Safety of Two Different Kinds of Cutting Balloon in Coronary Artery DiseaseCOMPLETEDNCT06832631VITUS Post-Market RegistryACTIVE_NOT_RECRUITINGNCT07397390an Observational Study Evaluting the Effectiveness and Safety of DKutting LL Noval Scoring Balloon Angioplasty for Vessel Preparation Facilitated by IVUS on the Lower Limb Ischemia Patients With Calcified LesionsENROLLING_BY_INVITATION

Other records listing Orbusneich Medical Trading, 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.

K200269Sapphire II PROK192344Sapphire NC Plus Coronary Dilatation CatheterK182713Scoreflex PTA Scoring Balloon CatheterK182360Teleport MicrocatheterK173680Sapphire II PROK173894Jade PTA Balloon Dilatation Catheter

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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.

K261428NC Euphora Rapid Exchange Balloon Dilatation CatheterMedtronic IrelandK261759Euphora Rapid Exchange (RX) Balloon Dilatation CatheterMedtronic IrelandK252116Firefighter™ Pro PTCA Balloon CatheterShanghai MicroPort Medical (Group) Co., Ltd.K254022FLASH Flex™ Aorto-Ostial Angioplasty SystemVerge Medical, Inc.K252295RyureiTerumo CorporationK251970Sprinter Legend Rapid Exchange Balloon Dilatation CatheterMedtronic, Ireland

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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