CPS Locator 3D Plus Delivery Catheter
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K250828 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 CPS Locator 3D Plus Delivery Catheter is a delivery catheter designed for the precise placement of venous stents within the cardiovascular system. It incorporates advanced 3D imaging and tracking capabilities to enhance accuracy during procedural interventions, ensuring optimal stent deployment in complex anatomical regions. This device is classified under the Cardiovascular category and is intended for use in interventional radiology and cardiology settings.
This catheter is supplied as a single-use, sterile device and is intended for reusable imaging systems compatible with fluoroscopy or other imaging modalities. It is regulated under FDA 510(k) clearance (K250828) and falls under the DQY product code, with a Special clearance type. The device is engineered for compatibility with standard catheterization laboratory workflows and adheres to MRI safety guidelines for non-ferromagnetic materials. Storage requires protection from moisture and extreme temperatures, as specified in the manufacturer’s instructions.
Frequently asked questions
What is the CPS Locator 3D Plus Delivery Catheter used for?
This catheter is designed specifically for the precise placement of venous stents within the cardiovascular system. Its advanced 3D imaging and tracking features enhance accuracy during interventional procedures, particularly in complex anatomical regions where traditional methods may fall short. This ensures optimal stent deployment, improving procedural outcomes in interventional radiology and cardiology settings.
Is the CPS Locator 3D Plus Delivery Catheter single-use or reusable?
The CPS Locator 3D Plus Delivery Catheter is supplied as a single-use device. This design choice minimizes cross-contamination risks and ensures consistent performance for each procedure, aligning with best practices for sterile medical instruments in catheterization labs.
What imaging systems is this catheter compatible with?
The catheter is intended for use with reusable imaging systems that support fluoroscopy or other imaging modalities. Its compatibility with these systems streamlines workflows in catheterization laboratories, allowing clinicians to leverage existing infrastructure while benefiting from the catheter’s advanced 3D imaging capabilities.
How should the CPS Locator 3D Plus Delivery Catheter be stored?
Storage requires protection from moisture and extreme temperatures. The manufacturer’s instructions provide specific guidelines to maintain the device’s integrity, ensuring it remains functional and safe for use when needed. Proper storage conditions help preserve sterility and performance for single-use applications.
Does the CPS Locator 3D Plus Delivery Catheter comply with MRI safety standards?
Yes, the catheter is engineered to adhere to MRI safety guidelines for non-ferromagnetic materials. This ensures it can be safely used in environments where MRI compatibility is required, reducing risks associated with magnetic interference during or after procedures.
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. Sources consulted: Products - centerpoint-systems.com, CPS Locator 3D Plus Delivery Catheter (K250828) — FDA 510(k ..., CPS Locator 3D Plus Delivery Catheter (K261766) — FDA 510(k ..., CPS Locator 3D Plus Delivery Catheter - Centerpoint Systems | FDA Reference
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K250828 | Class II | Active |
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Manufacturer
- Manufacturer
- CenterPoint Systems LLC
- FDA Applicant
- CenterPoint Systems, LLC
Sources (1)
- FDA 510(k) K250828 24 fields · synced Oct 1, 2026