Cleared Special

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

K171747 · Codman & Shurtleff, Inc. · Neurology

Jul 2017

Decision

31d

Days

Class 2

Risk

About This 510(k) Submission

K171747 is an FDA 510(k) clearance for the 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, a Device, Neurovascular Embolization (Class II — Special Controls, product code HCG), submitted by Codman & Shurtleff, Inc. (Raynham, US). The FDA issued a Cleared decision on July 14, 2017, 31 days after receiving the submission on June 13, 2017. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5950.

Submission Details

510(k) Number	K171747 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 13, 2017
Decision Date	July 14, 2017
Days to Decision	31 days
Submission Type	Special
Review Panel	Neurology (NE)
Summary	Summary PDF