Cleared Traditional

K183599 - Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging Catheter (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K183599 · Infraredx, Inc. · Cardiovascular device
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Apr 2019
Decision
107d
Days
Class 2
Risk

K183599 is an FDA 510(k) clearance for the Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging Catheter. Classified as Catheter, Intravascular, Plaque Morphology Evaluation (product code OGZ), Class II - Special Controls.

Submitted by Infraredx, Inc. (Burlington, US). The FDA issued a Cleared decision on April 12, 2019 after a review of 107 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Infraredx, Inc. devices

Submission Details

510(k) Number K183599 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 2018
Decision Date April 12, 2019
Days to Decision 107 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 125d · This submission: 107d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OGZ Catheter, Intravascular, Plaque Morphology Evaluation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.