Diagnostic Radiology Catheters
by American Edwards Laboratories 510(k)
Active
510(k) K834459
Overview
Diagnostic Radiology Catheters are medical devices used for diagnostic procedures in radiology. These catheters are designed to assist in various imaging and diagnostic interventions within the vascular system.
The device is supplied by American Edwards Laboratories and has received FDA 510(k) clearance with K number K834459. The product code is DQO, and it was cleared on February 4, 1984. Specific details regarding sterility, single-use or reusable status, MRI safety, and sizes are not provided in the available data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK834459 | Date4 Feb 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- Withdrawn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
- 510(k) Number
- FDA Product Code
- DQO
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1200
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Other devices from American Edwards Laboratories
Questions
What are Diagnostic Radiology Catheters used for?
Diagnostic Radiology Catheters are medical devices designed to assist in various imaging and diagnostic interventions within the vascular system. They are used during radiology procedures to facilitate diagnostic imaging of blood vessels and surrounding tissues.
What is the regulatory status of these catheters?
These catheters have received FDA 510(k) clearance with K number K834459. They were cleared on February 4, 1984, and are classified under product code DQO. The clearance was determined through the traditional review process.
Are these catheters single-use or reusable?
The available data does not specify whether Diagnostic Radiology Catheters are single-use or reusable. Similarly, information regarding sterility status, MRI safety, and available sizes is not provided in the device specifications.
Who manufactures these catheters and where are they located?
Diagnostic Radiology Catheters are manufactured by American Edwards Laboratories, located at 803 N. Front St. Suite 3, McHenry, IL 60050, United States. The company submitted the device for FDA clearance in December 1983.