Modified Angiographic Catheter
510(k) K896690
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK896690 | Date24 Jan 1990 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
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
Overview
AI-generated summary, 1 Oct 2026
The Modified Angiographic Catheter is an intravascular, diagnostic catheter designed for angiographic procedures. It facilitates the visualization of blood vessels by injecting contrast media, enabling detailed imaging of coronary and peripheral vasculature during angiography. This device aids in the diagnosis of vascular conditions such as stenosis, aneurysms, or blockages by providing real-time radiographic contrast.
This catheter is supplied as a single-use medical device and is intended for use in controlled clinical settings, such as cardiac catheterization laboratories. It is classified under the FDA’s product code DQO and has received a 510(k) clearance (K896690) under the Traditional review pathway, with a decision of Substantially Equivalent (SESE). No specific sterility or MRI safety information is provided in the available data, though standard aseptic techniques should be followed during handling and use.