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FDA PRODUCT CODE · CLASS II

ORD — Optical Coherence Tomography, Intravascular Catheter

For intravascular visualization of the coronary vessel lumen and wall in patients who are candidates for transluminal interventional procedures.

DEVICE CLASS
Class II
REGULATION
21 CFR 870.1200
MEDICAL SPECIALTY
Cardiovascular
REVIEW PANEL
CV
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
0
510(K)/PMA CLEARANCES
0
RECALL ENTRIES

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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