Sapphire NC ULTRA Coronary Dilatation Catheter
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K233499 FDA 510(k)
- FDA Product Code
- LOX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.5100 FDA 510(k)
- Regulation Number
- 870.5100 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Sapphire NC ULTRA Coronary Dilatation Catheter is a percutaneous transluminal coronary angioplasty catheter designed for the dilation of coronary arteries. It employs a balloon mechanism to mechanically widen narrowed or obstructed segments within coronary vessels, facilitating improved blood flow to the heart muscle. This device is classified as a Class II medical device under FDA regulations and is intended for use in interventional cardiology procedures.
The catheter is supplied as a single-use, non-sterile device and must be sterilized prior to use, typically via ethylene oxide or gamma irradiation. It is compatible with MRI environments under specified conditions and is available in multiple reference codes and sizes as listed in the regulatory filings. Authorized for use in the United States under FDA 510(k) clearance and compliant with the Medical Device Directive (MDD), it is intended for professional medical use in controlled clinical settings.
Frequently asked questions
What is the Sapphire NC ULTRA Coronary Dilatation Catheter used for in clinical practice?
The Sapphire NC ULTRA Coronary Dilatation Catheter is specifically designed for percutaneous transluminal coronary angioplasty, a procedure to mechanically widen narrowed or obstructed segments within coronary arteries. This improves blood flow to the heart muscle, addressing blockages that may restrict circulation and contribute to conditions like coronary artery disease.
Is the Sapphire NC ULTRA Coronary Dilatation Catheter intended for single-use or can it be reused?
The Sapphire NC ULTRA Coronary Dilatation Catheter is explicitly supplied as a single-use device. It must be sterilized prior to use, typically via ethylene oxide or gamma irradiation, which means it is not intended for reuse after sterilization.
What sterilization methods are recommended for the Sapphire NC ULTRA Coronary Dilatation Catheter?
The device is supplied in a non-sterile state and requires sterilization before use. The data indicates compatibility with ethylene oxide and gamma irradiation as suitable sterilization methods, though the specific parameters (e.g., exposure time, temperature) would depend on the manufacturer’s validated protocols.
How many sizes or models of the Sapphire NC ULTRA Coronary Dilatation Catheter are available?
The device is available in multiple reference codes and sizes, as listed in the regulatory filings (e.g., FEI numbers like 3015002281, 3002095335, etc.). These correspond to different catheter dimensions tailored for various coronary artery diameters and procedural needs. Exact measurements (e.g., balloon diameter, length) would be detailed in the manufacturer’s technical documentation.
Can the Sapphire NC ULTRA Coronary Dilatation Catheter be used in an MRI environment?
Yes, the Sapphire NC ULTRA Coronary Dilatation Catheter is compatible with MRI environments under specified conditions. However, the exact MRI safety parameters (e.g., magnetic field strength, imaging sequences) are not detailed in the provided data and would require review of the manufacturer’s MRI safety documentation or labeling.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K233499 | Class II | Active |
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Manufacturer
- Manufacturer
- OrbusNeich Medical (Shenzhen) Co., Ltd.
Sources (2)
- FDA 510(k) K233499 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026