510(k) K150319

MICRUSFRAME 10/18, DELTAFILL 18, DELTAXSFT 10, GALAXY G3 FILL/XSFT STRETCH RESISTANT MICROCOIL DELIVERY SYSTEMS by Codman & Shurtleff, Inc. — Product Code HCG

K150319 is an FDA 510(k) premarket notification submitted by Codman & Shurtleff, Inc. for the device "MICRUSFRAME 10/18, DELTAFILL 18, DELTAXSFT 10, GALAXY G3 FILL/XSFT STRETCH RESISTANT MICROCOIL DELIVERY SYSTEMS". The FDA issued a decision of Substantially Equivalent on June 12, 2015. The device falls under product code HCG (Device, Neurovascular Embolization), a Class II device regulated under 21 CFR 882.5950. Codman & Shurtleff, Inc. has at least 10 other 510(k) clearances on record.