QXZ — Adjunctive Epicardial Vascular Physiologic Status Indicator Class II
FDA product code QXZ covers "Adjunctive Epicardial Vascular Physiologic Status Indicator", a Class II medical device regulated under 21 CFR 870.2200. Submissions are reviewed by the Cardiovascular panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- QXZ
- Device Class
- Class II
- Regulation Number
- 870.2200
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Definition
The adjunctive epicardial vascular physiologic status indicator is a prescription device based on sensor technology or image data to provide information to an interpreting clinician in detecting the possible presence of functionally significant coronary artery disease to suggest the need for further testing. This device is intended for adjunctive use with other clinical workup or patient information and is not intended to quantify the degree to which epicardial disease is limiting flow through a vessel nor is it intended to independently direct therapy.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K231335 | cleerly | Cleerly ISCHEMIA | September 8, 2023 |