Orbusneich Medical Trading, Inc.
United StatesFDA applicant, unverified
- Devices
- 7
What Orbusneich Medical Trading, Inc. makes
OrbusNeich Medical Trading, Inc. manufactures percutaneous transluminal angioplasty (PTA) balloon catheters, including plain dilatation, scoring, and drug-eluting variants designed for coronary artery treatment. The Jade PTA Balloon Dilatation Catheter is intended for general vessel dilation, while the Scoreflex PTA Scoring Balloon Catheter incorporates scoring to enhance plaque disruption. The Sapphire NC Plus and Sapphire II PRO Balloon Dilatation Catheters are optimized for precise coronary artery intervention, supporting revascularization procedures.
The company’s devices are classified as Class II under FDA regulations and are listed in the 510(k) clearance registry. These products are intended for use in the United States, where regulatory compliance is required for market authorization. No other regulatory listings or jurisdictions are specified.
Catalogue
Sapphire II PRO Ref K173680
Regimes: 510(k) Registry: 510(k)Sapphire II PRO Ref K200269
Regimes: 510(k) Registry: 510(k)Teleport Microcatheter Ref K182360
Regimes: 510(k) Registry: 510(k)Jade PTA Balloon Dilatation Catheter Ref K173894
Regimes: 510(k) Registry: 510(k)Scoreflex PTA Scoring Balloon Catheter Ref K182713
Regimes: 510(k) Registry: 510(k)Sapphire NC Plus Coronary Dilatation Catheter Ref K192344
Regimes: 510(k) Registry: 510(k)Sapphire II PRO Balloon Dilatation Catheter Ref K180921
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Orbusneich Medical Trading, Inc. have in the registry?
The registry currently lists 7 devices for Orbusneich Medical Trading, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Orbusneich Medical Trading, Inc.'s devices?
Among its 7 most recently registered devices, Orbusneich Medical Trading, Inc. has devices listed in FDA 510(k) (7 devices).
What risk classes do Orbusneich Medical Trading, Inc.'s devices fall under?
Among its 7 most recently registered devices, the classes recorded for Orbusneich Medical Trading, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Orbusneich Medical Trading, Inc. in the registry?
The most recently registered devices listed for Orbusneich Medical Trading, Inc. include Sapphire II PRO, Teleport Microcatheter, Jade PTA Balloon Dilatation Catheter and Scoreflex PTA Scoring Balloon Catheter.