Clearance Summary
MICRUSFRAME 10 Stretch Resistant Microcoil Delivery System, MICRUSFRAME 18 Stretch Resistant Microcoil Delivery System, DELTAFILL 18 Stretch Resistant Microcoil Delivery System, DELTAXSFT 10 Stretch Resistant Microcoil Delivery System, GALAXY G3 FILL and GALAXY G3 XSFT Stretch Resistant Microcoil Delivery System received FDA 510(k) clearance under submission number K171747, sponsored by Codman & Shurtleff, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2017-07-14.
- Submission: K171747
- Applicant / Sponsor: Codman & Shurtleff, Inc.
- Clearance pathway: Special
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5950
- Decision date: 2017-07-14
Classification & Regulation
This clearance is catalogued under FDA product code HCG and 21 CFR 882.5950, within the Neurology review panel as a Class II device.