Product code OGZ

Device name

Catheter, Intravascular, Plaque Morphology Evaluation

Medical specialty

Cardiovascular

Device class

2

Regulation number

870.1200

Review panel

CV

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

Definition

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.

Source

FDA openFDA device classification dataset