Right Atrial Catheter
by Quinton, Inc. 510(k)
Active
510(k) K822964
Overview
This device is a catheter, subclavian (product code LFJ), designed for insertion into the right atrium of the heart via venous access. It facilitates procedures such as fluid administration, blood sampling, and hemodynamic monitoring by providing a lumen for direct access to the cardiac chamber. The catheter is intended for use in clinical settings where precise intracardiac interventions are required, such as intensive care or cardiac catheterization labs.
The Right Atrial Catheter is supplied sterile and intended for single-use, adhering to Class II regulatory standards under FDA 510(k) clearance (K822964). It is manufactured by Quinton, Inc. and must be handled in accordance with aseptic techniques. The device is not MRI-compatible and should be stored in a clean, dry environment as specified by the manufacturer. No additional regulatory approvals beyond the stated 510(k) clearance are referenced in the available data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK822964 | Date30 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- Withdrawn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 Right Atrial Catheter designed for?
The Right Atrial Catheter is specifically designed for insertion into the right atrium of the heart via venous access, typically through the subclavian vein. It provides a lumen for direct intracardiac access, facilitating procedures such as fluid administration, blood sampling, and hemodynamic monitoring. This makes it ideal for use in intensive care units or cardiac catheterization labs where precise cardiac interventions are required.
Is the Right Atrial Catheter sterile and single-use?
Yes, the Right Atrial Catheter is supplied sterile and intended for single-use only. This design ensures patient safety by minimizing the risk of infection and contamination, adhering to best practices for medical devices used in invasive procedures.
What storage conditions are recommended for this catheter?
The catheter must be stored in a clean, dry environment as specified by the manufacturer. Proper storage conditions help maintain its integrity and sterility, ensuring it remains suitable for clinical use when needed.
Can the Right Atrial Catheter be used with MRI equipment?
No, the Right Atrial Catheter is not MRI-compatible. This means it should not be used in or near MRI machines, as the magnetic fields could potentially damage the device or pose safety risks to the patient.
What regulatory clearance does this catheter hold?
The Right Atrial Catheter holds FDA 510(k) clearance under the classification of Class II medical devices. This clearance indicates that the device has been deemed substantially equivalent to a legally marketed predicate device, meeting the necessary regulatory standards for safety and effectiveness.