SSPC NXT Delivery Catheter
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K243180 FDA 510(k)
- FDA Product Code
- DQY FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1250 FDA 510(k)
- Regulation Number
- 870.1250 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The SSPC NXT Delivery Catheter is a Delivery Catheter designed for use in cardiovascular procedures. It facilitates the precise placement of devices such as stents or occlusion coils within blood vessels, leveraging its specialized design for controlled deployment and navigation through complex vascular anatomy.
This catheter is supplied sterile and intended for single-use, adhering to FDA 510(k) clearance under Special Review (K243180) and meeting the requirements of the Medical Device Directive (MDD). It is intended for use in clinical settings where vascular interventions are performed, with no specific MRI safety classification noted. Sizes and configurations are standardized for compatibility with standard delivery systems in interventional cardiology.
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 | K243180 | Class II | Active |
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Manufacturer
- Manufacturer
- CenterPoint Systems LLC
- FDA Applicant
- CenterPoint Systems, LLC
Sources (2)
- FDA 510(k) K243180 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026