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Percutaneous Catheter, Ultrasound

FDA product code PPN · 14 cleared devices

Class 2 Cardiovascular
Regulation
21 CFR 870.1250
Review panel
CV
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2016-09-14 – 2026-08-24

Intended for ultrasound wave enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature.

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