FDA product code PDU

Catheter For Crossing Total Occlusions

Cardiovascular·Class 2·21 CFR 870.1250
US regulatory classifications
US Product Code (FDA)
PDU
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 870.1250
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Medical specialty
Cardiovascular
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
Definition

To facilitate the intraluminal placement of conventional guidewires beyond stenotic lesions (including subchronic and chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention, such as angioplasty, atherectomy or stent placement.

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About this record

Catheter For Crossing Total Occlusions 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.