Solex Intravascular Heat Exchange Catheter
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K141139 FDA 510(k)
- FDA Product Code
- NCX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.5900 FDA 510(k)
- Regulation Number
- 870.5900 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Solex Intravascular Heat Exchange Catheter is a System, Hypothermia, Intravenous, Cooling device classified under the FDA’s Class II regulatory framework. It is designed to facilitate intravascular temperature management by circulating temperature-controlled sterile saline through a heat exchanger, enabling controlled cooling or warming of the patient’s blood. This catheter is intended for placement within the superior vena cava via the jugular or subclavian vein, providing a non-invasive alternative to central line-based cooling systems. Its primary function is to regulate core body temperature in clinical settings where precise thermal control is required, such as during perioperative hypothermia management or fever control.
The device is supplied as a sterile, single-use flexible catheter with a 9.3 French diameter and lengths of 20 cm. It is intended for use in cardiovascular applications and must be paired with a compatible temperature management system (e.g., Thermogard or Coolgard) to achieve therapeutic temperature adjustments. The catheter adheres to FDA 510(k) clearance (K141139) under the Traditional review pathway, with a Substantially Equivalent determination by the Cardiovascular (CV) Advisory Committee. Storage and handling must comply with sterile medical device protocols to ensure integrity prior to use.
Frequently asked questions
What clinical scenarios is the Solex Intravascular Heat Exchange Catheter primarily used for, and how does it differ from traditional cooling methods?
The Solex catheter is designed for precise intravascular temperature management, particularly in situations requiring controlled hypothermia or fever reduction, such as perioperative hypothermia management. Unlike central line-based cooling systems, it provides a non-invasive alternative by circulating temperature-controlled saline directly through the catheter placed in the superior vena cava via the jugular or subclavian vein. This method avoids the need for direct central line insertion while still enabling effective thermal regulation.
Is the Solex catheter reusable, and if not, what are the implications for clinical workflow and inventory management?
No, the Solex catheter is explicitly labeled as a single-use device. This design ensures sterility and reduces infection risks, but it does require clinicians to plan for immediate disposal after use. Inventory management must account for frequent restocking, and workflows should include proper handling and disposal protocols to maintain compliance with sterile medical device standards.
What temperature management systems are compatible with the Solex catheter, and why is compatibility important?
The Solex catheter is designed to work with compatible temperature management systems like Thermogard or Coolgard. Compatibility is critical because these systems control the saline temperature circulated through the catheter, enabling precise cooling or warming of the patient’s blood. Using an incompatible system could compromise thermal regulation effectiveness or device functionality.
How should the Solex catheter be stored, and what precautions must be taken to ensure its sterility before use?
The catheter must be stored following sterile medical device protocols to preserve its integrity. Since it is supplied sterile, it should remain in its original packaging until immediately before use, protected from contamination. Storage conditions should comply with manufacturer guidelines to prevent damage, and the packaging should not be opened until the device is ready for insertion.
What size and placement considerations should clinicians keep in mind when using the Solex catheter?
The Solex catheter has a 9.3 French diameter and lengths of 20 cm, designed for placement within the superior vena cava via the jugular or subclavian vein. Clinicians must ensure proper sizing for the patient’s anatomy and confirm compatibility with the chosen insertion site to avoid complications. The catheter’s flexibility and intended placement route are optimized for cardiovascular applications, but anatomical variations may require careful assessment.
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: 106939-001 Rev 3 Solex IFU - ZOLL Medical, 106482-003 Rev 2 Solex 7 20 cm US IFU - ZOLL Medical, Solex 7 Brochure - ZOLL
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K141139 | Class II | Active |
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Manufacturer
- Manufacturer
- Zoll Circulation
Sources (1)
- FDA 510(k) K141139 24 fields · synced Sep 20, 2026