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FDA 510(k)

Sapphire ULTRA Coronary Dilatation Catheter

K-Number: K233505 · 2024-08-15

ApplicantOrbusNeich Medical (Shenzhen) Co., Ltd.
Decision Date2024-08-15
Product CodeLOX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Sapphire ULTRA Coronary Dilatation Catheter is a medical device manufactured by OrbusNeich Medical (Shenzhen) Co., Ltd.. It received FDA 510(k) clearance on 2024-08-15 under approval number K233505. 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 ULTRA Coronary Dilatation Catheter?

Sapphire ULTRA Coronary Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2024-08-15. It is manufactured by OrbusNeich Medical (Shenzhen) Co., Ltd.. The 510(k) number is K233505.

When was Sapphire ULTRA Coronary Dilatation Catheter approved by the FDA?

Sapphire ULTRA Coronary Dilatation Catheter received FDA 510(k) clearance on 2024-08-15, under approval number K233505.

What company makes Sapphire ULTRA Coronary Dilatation Catheter?

Sapphire ULTRA Coronary Dilatation Catheter is manufactured by OrbusNeich Medical (Shenzhen) Co., Ltd..

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

The FDA product code for Sapphire ULTRA Coronary Dilatation Catheter is LOX.

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Other Devices by OrbusNeich Medical (Shenzhen) Co., Ltd.

K202231JADE K201794Jade K211807Sapphire NC 24 K233499Sapphire NC ULTRA Coronary Dilatation Catheter K241025JADE PLUS PTA Balloon Dilatation Catheter K231608Teleport XT Microcatheter

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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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