Reprieve Endovascular Temperature Therapy System
510(k) K063405
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK063405 | Date8 Jan 2007 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- NCX
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.5900
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Reprieve Endovascular Temperature Therapy System is a thermal regulating device that utilizes endovascular heat exchange to modulate patient body temperature. It rapidly achieves and maintains a user-defined patient target temperature within the range of 32-37°C by circulating warm or cool saline through the catheter.
The system is used in clinical settings such as the operating room and intensive care unit by healthcare professionals to induce, maintain, and reverse mild hypothermia in neurosurgical patients during surgery and in recovery/intensive care. It is supplied as a system for use in these environments, with no indication of sterility, single-use or reusable status, MRI safety, specific sizes, storage conditions, or additional authorisations beyond the FDA 510(k) clearance referenced in the data.
Other devices from Radiant Medical
Questions
AI-generated answers, 1 Oct 2026
What is the Reprieve Endovascular Temperature Therapy System used for?
The system is used to induce, maintain, and reverse mild hypothermia in neurosurgical patients during surgery and in recovery or intensive care by regulating body temperature between 32-37°C through endovascular heat exchange.
How does the Reprieve System achieve temperature control?
It circulates warm or cool saline through an endovascular catheter to rapidly achieve and maintain a user-defined target temperature within the 32-37°C range via heat exchange with the patient's blood.
In which clinical settings is the Reprieve System intended for use?
The system is designed for use in operating rooms and intensive care units by healthcare professionals managing neurosurgical patients requiring temperature modulation during procedures and postoperative care.