Sapphire NC 24
K-Number: K211807 · 2021-10-14
Decision Date2021-10-14
Product CodeLOX
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Sapphire NC 24 is a medical device manufactured by OrbusNeich Medical (Shenzhen) Co., Ltd.. It received FDA 510(k) clearance on 2021-10-14 under approval number K211807. 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 24?
Sapphire NC 24 is a medical device that received FDA 510(k) clearance on 2021-10-14. It is manufactured by OrbusNeich Medical (Shenzhen) Co., Ltd.. The 510(k) number is K211807.
When was Sapphire NC 24 approved by the FDA?
Sapphire NC 24 received FDA 510(k) clearance on 2021-10-14, under approval number K211807.
What company makes Sapphire NC 24?
Sapphire NC 24 is manufactured by OrbusNeich Medical (Shenzhen) Co., Ltd..
What is the FDA product code for Sapphire NC 24?
The FDA product code for Sapphire NC 24 is LOX.
Other Devices by OrbusNeich Medical (Shenzhen) Co., Ltd.
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.