Infusion Port Balloon Thermodilution Catheter
by Critikon Company, LLC 510(k)
Active
510(k) K833918
Overview
This device is a Flow-Directed Catheter designed for thermodilution measurements, specifically to assess cardiac output and related hemodynamic parameters. It incorporates an inflatable balloon to facilitate accurate positioning within the pulmonary artery, enabling precise thermal dilution techniques for monitoring cardiac function in clinical settings.
The catheter is intended for single-use and is regulated under FDA 510(k) clearance (K833918) as a Class II medical device (DYG product code). It is supplied sterile and requires sterile handling procedures. The device is not MRI-compatible and must be used in appropriate clinical environments where hemodynamic monitoring is performed, such as intensive care units or cardiac catheterization labs.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK833918 | Date30 Jan 1984 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- Full name
- Infusion Port Balloon Thermodilution
- 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
Other devices from Critikon Company, LLC
Questions
What is the primary purpose of the Infusion Port Balloon Thermodilution Catheter?
This catheter is designed specifically for thermodilution measurements to assess cardiac output and related hemodynamic parameters. The inflatable balloon helps position the catheter accurately within the pulmonary artery, ensuring precise monitoring of cardiac function in critical care settings like intensive care units or cardiac catheterization labs.
Is this device intended for single-use or reusable applications?
The Infusion Port Balloon Thermodilution Catheter is intended for single-use only. This design ensures patient safety by preventing cross-contamination and maintaining sterility, which is critical for accurate hemodynamic monitoring in clinical environments.
How is the catheter supplied, and what handling precautions must be taken?
The device is supplied sterile and must be handled using sterile procedures to maintain its integrity. Since it is a single-use catheter, it should only be used once per patient and then discarded. Proper sterile technique is essential to prevent infection and ensure accurate measurements.
Can this catheter be used in environments where MRI is performed?
No, this catheter is not MRI-compatible. It should only be used in clinical settings where MRI equipment is not present, such as standard intensive care units or cardiac catheterization labs, to avoid interference or safety risks.
What regulatory clearance does this device hold, and what class does it belong to?
The Infusion Port Balloon Thermodilution Catheter holds FDA 510(k) clearance (K833918) and is classified as a Class II medical device under the DYG product code. This classification indicates it is subject to special controls to ensure its safety and effectiveness for measuring cardiac output and hemodynamic parameters.