← FDA Medical Device Classifications

Catheter, Intravascular, Plaque Morphology Evaluation

OGZ · Class II — Moderate Risk (510(k) clearance required) · Cardiovascular · 21 CFR 870.1200

Classification

FDA Product Code: OGZ
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 870.1200
Review panel: CV
Medical specialty: Cardiovascular
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 9
Registered establishments: 6

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown