Swan-Ganz VIP Thermodilution Catheter
by American Edwards Laboratories
510(k) K810124
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK810124 | Date4 Feb 1981 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- DYG
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1240
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Swan-Ganz VIP Thermodilution Catheter is a flow-directed pulmonary artery catheter designed for hemodynamic monitoring. It measures cardiac output via thermodilution principles, providing real-time data on flow, pressure, and oxygen dynamics within the cardiovascular system. The device incorporates multiple lumens, including an additional lumen for direct right atrial access, enabling comprehensive hemodynamic assessment when paired with a cardiac output monitor.
This catheter is intended for single-use in clinical settings such as intensive care units and cardiac catheterization labs. It is supplied sterile and requires no additional sterilization. The device is classified as a Class II medical device under FDA regulations (DYG, 870.1240) and holds a 510(k) clearance for substantial equivalence. Available in sizes such as 7.5 French (e.g., Models 831F75, 831F75P, 831VF75P), it must be stored under controlled conditions to maintain integrity.
Other devices from American Edwards Laboratories
Questions
AI-generated answers, 1 Oct 2026
What is the Swan-Ganz VIP Thermodilution Catheter used for?
The Swan-Ganz VIP Thermodilution Catheter is designed for hemodynamic monitoring in critical care settings. It measures cardiac output using thermodilution principles, providing real-time data on blood flow, pressure, and oxygen dynamics within the cardiovascular system. This helps clinicians assess cardiac function, guide fluid management, and monitor patients in intensive care units (ICUs) or cardiac catheterization labs.
How is the Swan-Ganz VIP Thermodilution Catheter supplied, and is it reusable?
The catheter is supplied sterile and intended for single-use only. It does not require additional sterilization before use. This ensures patient safety by preventing cross-contamination and maintains the device’s performance integrity for one-time clinical application.
What sizes are available for the Swan-Ganz VIP Thermodilution Catheter?
This catheter is available in 7.5 French (Fr) sizes, including models such as 831F75, 831F75P, and 831VF75P. The French size corresponds to the catheter’s outer diameter, which determines its suitability for different patient anatomies. Always verify the model and size match your clinical needs before use.
How should the Swan-Ganz VIP Thermodilution Catheter be stored?
The catheter must be stored under controlled conditions to preserve its integrity and sterility. This includes maintaining proper temperature, humidity, and protection from physical damage. Follow manufacturer guidelines for packaging and storage to ensure the device remains functional and safe for single-use.
Does the Swan-Ganz VIP Thermodilution Catheter require any special handling for thermodilution measurements?
Yes, accurate thermodilution measurements depend on proper calibration and use with a compatible cardiac output monitor. The catheter’s thermistor detects temperature changes when a cold saline solution is injected, allowing the monitor to calculate cardiac output. Ensure the monitor is calibrated and the injection technique follows clinical protocols for reliable results.