510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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OGZClass II

Catheter, Intravascular, Plaque Morphology Evaluation

21 CFR 870.1200 / Cardiovascular
FDA source (opens on fda.gov)

OGZ is the FDA product code for Catheter, Intravascular, Plaque Morphology Evaluation, a class II device type, regulated under 21 CFR 870.1200. FDA's definition for this code reads: "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". As of , FDA records hold 9 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
OGZ
Device name
Catheter, Intravascular, Plaque Morphology Evaluation
FDA 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.
Regulation
21 CFR 870.1200
Device class
Class II
Review panel
Cardiovascular
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
9
Ingested recalls
1

Clearances, product code OGZ

By decision year
9 clearances under product code OGZ with a decision year between 2008 and 2025, 2013 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code OGZ by decision year
YearClearances
20081
20101
20132
20142
20171
20191
20251

Applicants with the most clearances

Product code OGZ
Applicants holding the most 510(k) clearances under product code OGZ
ApplicantClearances
Nipro Vascular Innovations Americas, Inc.9

Companies listing this code with FDA

Companies whose registered establishments list this code