510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K183599Substantially Equivalent

Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging Catheter

Nipro Vascular Innovations Americas, Inc., Burlington MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K183599 is the FDA 510(k) clearance record for Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging Catheter, a class II device, cleared for Infraredx, Inc. on under FDA product code OGZ (Catheter, Intravascular, Plaque Morphology Evaluation). FDA's definition for product code OGZ 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...". FDA records list 11 510(k) clearances for Nipro Vascular Innovations Americas, Inc., from to . As of , FDA records show no recalls naming K183599.

Clearance record

Decision date
Received
(107 days to decision)
Product code
OGZ Catheter, Intravascular, Plaque Morphology Evaluation
Regulation
21 CFR 870.1200
Device class
Class II
Review panel
Cardiovascular
Applicant
Infraredx, Inc. 34 Third Ave., Burlington MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OGZ

Trailing 12 months

FDA records hold no clearances under product code OGZ in the trailing twelve months.

FDA records show no clearances under product code OGZ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OGZ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260