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Adjunctive Epicardial Vascular Physiologic Status Indicator

FDA product code QXZ · 1 cleared devices

Class 2 Cardiovascular
Regulation
21 CFR 870.2200
Review panel
CV
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2023-09-08 – 2023-09-08

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.

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