Device classification

Optical Coherence Tomography, Intravascular Catheter

Cardiovascular · 21 CFR 870.1200

Class IIProduct code ORD
Open FDA's page for this record
Third party flag
N
Life sustain support flag
N
Gmp exempt flag
N
Summary malfunction reporting
Eligible
Product code
ORD
Review panel
CV
Medical specialty
CV
Device name
Optical Coherence Tomography, Intravascular Catheter
Medical specialty description
Cardiovascular
Device class
2
Definition
For intravascular visualization of the coronary vessel lumen and wall in patients who are candidates for transluminal interventional procedures.
Regulation number
870.1200
Implant flag
N
Submission type ID
1
Harmonized identifiers (openFDA)
Registration number
3009882464, 3011578544, 9611665, 1220477, 2245304, 3017654247, 2246552, 3021630097, 2024311
FEI number
3009882464, 3011578544, 1220477, 2245304, 3017654247, 2246552, 3021630097, 3002807095, 2024311
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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.