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FDA 510(k)

Sapphire NC ULTRA Coronary Dilatation Catheter

K-Number: K233499 · 2024-08-16

ApplicantOrbusNeich Medical (Shenzhen) Co., Ltd.
Decision Date2024-08-16
Product CodeLOX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Sapphire NC ULTRA Coronary Dilatation Catheter is the device name listed in this FDA 510(k) record. The listed applicant is OrbusNeich Medical (Shenzhen) Co., Ltd.. It received FDA 510(k) clearance on 2024-08-16 under 510(k) number K233499. 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 NC ULTRA Coronary Dilatation Catheter?

Sapphire NC ULTRA Coronary Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2024-08-16. The listed applicant is OrbusNeich Medical (Shenzhen) Co., Ltd.. The 510(k) number is K233499.

When did Sapphire NC ULTRA Coronary Dilatation Catheter receive FDA 510(k) clearance?

Sapphire NC ULTRA Coronary Dilatation Catheter received FDA 510(k) clearance on 2024-08-16, under 510(k) number K233499.

Who is the listed applicant for Sapphire NC ULTRA Coronary Dilatation Catheter?

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

What is the FDA product code for Sapphire NC ULTRA Coronary Dilatation Catheter?

The FDA product code for Sapphire NC ULTRA Coronary 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 DiseaseCOMPLETED

Other records listing OrbusNeich Medical (Shenzhen) Co., 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.

PMA P200041Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoringK253361Teleport Glide MicrocatheterK242588COREPASS Modular Microcatheter (FLEX); COREPASS Modular Microcatheter (CONTROL)K233505Sapphire ULTRA Coronary Dilatation CatheterK241025JADE PLUS PTA Balloon Dilatation CatheterK231608Teleport XT Microcatheter

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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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