FDA product code LOX

Catheters, Transluminal Coronary Angioplasty, Percutaneous

Cardiovascular·Class 2·21 CFR 870.5100
US regulatory classifications
US Product Code (FDA)
LOX
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 870.5100
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Medical specialty
Cardiovascular
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
Definition

A PTCA catheter is a device that operates on the principle of hydraulic pressurization applied through an inflatable balloon attached to the distal end.

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About this record

Catheters, Transluminal Coronary Angioplasty, Percutaneous is a medical device type in the Cardiovascular specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.