Right Arterial Catheter
by Quinton, Inc. 510(k)
Active
510(k) K822910
Overview
The Right Arterial Catheter is a medical device classified as a catheter, subclavian, designed for vascular access. It is used to measure arterial blood pressure and obtain blood samples from the right arterial system, typically the right radial or brachial artery, to monitor hemodynamic status in clinical settings. This device facilitates real-time assessment of circulatory function, particularly in critical care environments where precise monitoring is essential.
This catheter is supplied sterile and intended for single-use. It is regulated under FDA 510(k) clearance (K822910) and falls under product code LFJ, adhering to regulatory standards for Class II devices. Available in various sizes, it is intended for use in procedures within gastroenterology and urology specialties, though its primary function remains hemodynamic monitoring. Storage and handling must comply with sterile medical device protocols to ensure patient safety.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK822910 | Date29 Nov 1982 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 5 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- LFJ
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.5540
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Quinton, Inc.
Questions
What is the primary use of the Right Arterial Catheter from Quinton?
The Right Arterial Catheter is designed for measuring arterial blood pressure and obtaining blood samples from the right arterial system, such as the right radial or brachial artery. This enables real-time assessment of hemodynamic status, which is critical in high-acuity settings like intensive care units or during surgical procedures where circulatory function must be closely monitored.
How is the Right Arterial Catheter supplied, and is it reusable?
The catheter is supplied sterile and is intended for single-use only. Reuse is not recommended due to potential contamination risks and the loss of sterility, which could compromise patient safety. Always follow sterile medical device protocols during handling and storage to maintain integrity.
What sizes are available for the Right Arterial Catheter, and how do I select the right one?
The Right Arterial Catheter is available in multiple sizes, as indicated by the OpenFDA registration numbers (e.g., 1000138054, 3003737899, etc.). Selection depends on patient anatomy, procedural requirements, and clinical guidelines. Consult manufacturer documentation or a healthcare professional to match the catheter size to the patient’s arterial diameter and intended use, ensuring proper function and minimizing complications.
How should the Right Arterial Catheter be stored to ensure sterility?
The catheter must be stored in its original, sealed packaging until use to preserve sterility. Store in a clean, dry environment away from direct sunlight, extreme temperatures, or sources of contamination. Avoid exposure to moisture or physical damage, as these can compromise the sterile barrier. Always adhere to the manufacturer’s storage instructions to maintain device integrity and patient safety.
Is the Right Arterial Catheter regulated under specific FDA standards, and what class does it belong to?
Yes, the Right Arterial Catheter is regulated under FDA 510(k) clearance (K822910) and classified as a Class II device under product code LFJ. This classification reflects its role in measuring arterial pressure—a function requiring performance standards to ensure safety and effectiveness. The device adheres to regulatory requirements for vascular access catheters, including design controls and labeling compliance.