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Catheter, Intravascular, Plaque Morphology Evaluation

FDA product code OGZ · 7 cleared devices

Class 2 Cardiovascular
Regulation
21 CFR 870.1200
Review panel
CV
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2008-04-25 – 2025-02-26

Catheter used for delivery of a sensing modality to a coronary or peripheral artery region for determination of atherosclerotic plaque characteristics. For examination of morphologic features of coronary or peripheral artery lesions or plaques.

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