Angiographic Catheter (K821816)
by Medi-Tech, Inc. 510(k)
Active
510(k) K821816
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK821816 | Date24 Aug 1982 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- Full name
- Angiographic Catheter
- 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
Overview
AI-generated summary, 1 Oct 2026
An angiographic catheter is a diagnostic device classified under the nomenclature for intravascular catheters, designed for visualizing blood vessels via angiography. It facilitates the injection of contrast media to enhance radiographic imaging of coronary and peripheral arteries, aiding in the diagnosis of vascular conditions. The device is engineered for precise navigation through the vascular system, ensuring accurate placement for optimal imaging results.
This catheter is supplied sterile and intended for single-use, adhering to traditional FDA 510(k) clearance under product code DQO. It is intended for use in clinical settings such as cardiac catheterization labs, where MRI safety is not applicable due to its metallic components. Sizes and configurations are determined by the specific vascular access requirements, and storage must comply with sterile packaging protocols. The device holds an FDA 510(k) clearance (K821816) and is regulated under the Cardiovascular advisory committee classification.
Other devices from Medi-Tech, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Medi-Tech angiographic catheter designed for?
This catheter is specifically designed for angiography, allowing clinicians to inject contrast media into blood vessels to visualize coronary and peripheral arteries via radiographic imaging. Its precision engineering ensures accurate placement within the vascular system, which is critical for diagnosing vascular conditions such as blockages or abnormalities.
Is the Medi-Tech angiographic catheter sterile and single-use?
Yes, the catheter is supplied sterile and intended for single-use only. This design minimizes infection risks and ensures consistent performance, adhering to standard medical device safety protocols for diagnostic procedures.
Can this catheter be used in an MRI environment?
No, this catheter is not MRI-safe due to its metallic components. It is explicitly designed for use in clinical settings like cardiac catheterization labs where MRI compatibility is not required, ensuring safe and effective diagnostic imaging.
How are sizes and configurations determined for this catheter?
The sizes and configurations of the Medi-Tech angiographic catheter are tailored to specific vascular access requirements. This flexibility allows clinicians to select the appropriate catheter based on the patient’s anatomy and the intended procedure, ensuring optimal imaging results.
What storage instructions apply to the sterile packaging of this catheter?
The catheter must be stored according to the sterile packaging protocols provided by Medi-Tech, Inc. This ensures the device remains uncontaminated and ready for use. Always follow the manufacturer’s guidelines to maintain sterility until the time of use.