Quattro Catheter Model IC4593
by Alsius Corp.
510(k) K070161
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK070161 | Date15 Feb 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- Withdrawn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 Quattro Catheter Model IC4593 is a system for intravenous cooling, classified under FDA regulation 870.5900 as a Class II device. It is designed to regulate body temperature by inducing, maintaining, or reversing mild hypothermia, as well as achieving and sustaining normothermia during surgical and intensive care procedures. Primarily used in cardiovascular and neurosurgical settings, it facilitates thermal management to support patient stability during critical interventions.
This catheter is intended for single-use and must be connected to an Alsius Catheter Thermal Regulation System for operation. Supplied sterile, it is regulated under FDA 510(k) clearance (K070161) with a decision of Substantially Equivalent (SESE). The device adheres to medical specialty classifications for cardiovascular applications and is categorized under product code NCX. Storage and handling must comply with sterile medical device protocols to ensure functionality and patient safety.
Other devices from Alsius Corp.
Questions
AI-generated answers, 1 Oct 2026
What is the Quattro Catheter Model IC4593 used for?
The Quattro Catheter Model IC4593 is designed for intravenous cooling to induce, maintain, or reverse mild hypothermia, as well as achieve and sustain normothermia during surgical and intensive care procedures. It is primarily used in cardiovascular and neurosurgical settings to help stabilize patients during critical interventions by regulating their body temperature.
How is the Quattro Catheter Model IC4593 supplied and prepared for use?
The Quattro Catheter Model IC4593 is supplied sterile and intended for single-use only. It must be connected to an Alsius Catheter Thermal Regulation System to function properly. Before use, ensure the device remains sterile and follow sterile medical device handling protocols to maintain its integrity and patient safety.
Is the Quattro Catheter Model IC4593 reusable?
No, the Quattro Catheter Model IC4593 is explicitly designed for single-use only. Reusing this device could compromise sterility and patient safety, so it must be discarded after one use.
What regulatory approval does the Quattro Catheter Model IC4593 hold?
The Quattro Catheter Model IC4593 is FDA-cleared under the 510(k) pathway with clearance number K070161. It is classified as a Class II device under FDA regulation 870.5900 and is categorized under product code NCX for cardiovascular applications. The device was determined to be Substantially Equivalent (SESE) by the FDA.
How should the Quattro Catheter Model IC4593 be stored?
The Quattro Catheter Model IC4593 must be stored according to sterile medical device protocols to ensure its functionality and safety. Since it is single-use and sterile upon packaging, it should be kept in its original packaging until ready for use, protected from contamination and physical damage.