510(k) clearances

Makoto Intravascular Imaging System™ (VC-MC10 / TVC-MC10i); Dualpro™ IVUS+NIRS Imaging Catheter (TVC-C195-42); Peripheral 014 Imaging Catheter (TVC-E195-42 )

Infraredx, Inc. · Cardiovascular

K241576Substantially EquivalentTraditionalOGZ
Open FDA's page for this record
Third party flag
N
City
Bedford
Advisory committee description
Cardiovascular
Address 1
28 Crosby Dr.
Address 2
Suite 100
Statement or summary
Summary
Product code
OGZ
Zip code
01730
Applicant
Infraredx, Inc.
Decision date
2025-02-26
Decision code
SESE
Country code
US
Device name
Makoto Intravascular Imaging System™ (VC-MC10 / TVC-MC10i); Dualpro™ IVUS+NIRS Imaging Catheter (TVC-C195-42); Peripheral 014 Imaging Catheter (TVC-E195-42 )
Advisory committee
CV
Contact
Stephen Sum
K number
K241576
State
MA
Date received
2024-06-03
Review advisory committee
CV
Postal code
01730
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Catheter, Intravascular, Plaque Morphology Evaluation
Medical specialty description
Cardiovascular
Regulation number
870.1200
Device class
2
Registration number
3017654247, 3015551113, 2245304, 1061124, 1220477, 8043817
FEI number
3015551113, 3003094575, 2245304, 1000512168, 1220477, 3017654247
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.