510(k) K211344

MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, GALAXY G3 XSFT, and GALAXY G3 Mini Microcoil Delivery Systems by Medos International SARL — Product Code HCG

K211344 is an FDA 510(k) premarket notification submitted by Medos International SARL for the device "MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, GALAXY G3 XSFT, and GALAXY G3 Mini Microcoil Delivery Systems". The FDA issued a decision of Substantially Equivalent on May 28, 2021. The device falls under product code HCG (Device, Neurovascular Embolization), a Class II device regulated under 21 CFR 882.5950. Medos International SARL has at least 10 other 510(k) clearances on record.