510(k) K251383

Prestige Coil System (Prestige Packing Line Extension) by Balt USA, LLC — Product Code KRD

K251383 is an FDA 510(k) premarket notification submitted by Balt USA, LLC for the device "Prestige Coil System (Prestige Packing Line Extension)". The FDA issued a decision of Substantially Equivalent on May 30, 2025. The device falls under product code KRD (Device, Vascular, For Promoting Embolization), a Class II device regulated under 21 CFR 870.3300. Balt USA, LLC has at least 10 other 510(k) clearances on record.