510(k) K250079

Ruby XL System by Penumbra, Inc. — Product Code KRD

K250079 is an FDA 510(k) premarket notification submitted by Penumbra, Inc. for the device "Ruby XL System". The FDA issued a decision of Substantially Equivalent on March 14, 2025. The device falls under product code KRD (Device, Vascular, For Promoting Embolization), a Class II device regulated under 21 CFR 870.3300. Penumbra, Inc. has at least 10 other 510(k) clearances on record.