FDA 510(k) Applications Submitted by OrbusNeich Medical (Shenzhen) Co., Ltd.

FDA 510(k) Number Submission Date Device Name Applicant
K211807 06/11/2021 Sapphire NC 24 OrbusNeich Medical (Shenzhen) Co., Ltd.
K201794 06/30/2020 Jade OrbusNeich Medical (Shenzhen) Co., Ltd.
K202231 08/07/2020 JADE OrbusNeich Medical (Shenzhen) Co., Ltd.
K242588 08/30/2024 COREPASS Modular Microcatheter (FLEX); COREPASS Modular Microcatheter (CONTROL) OrbusNeich Medical (Shenzhen) Co., Ltd.
K241025 04/15/2024 JADE PLUS PTA Balloon Dilatation Catheter OrbusNeich Medical (Shenzhen) Co., Ltd.
K231608 06/02/2023 Teleport XT Microcatheter OrbusNeich Medical (Shenzhen) Co., Ltd.
K233499 10/31/2023 Sapphire NC ULTRA Coronary Dilatation Catheter OrbusNeich Medical (Shenzhen) Co., Ltd.
K233505 10/31/2023 Sapphire ULTRA Coronary Dilatation Catheter OrbusNeich Medical (Shenzhen) Co., Ltd.


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