Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name device, neurovascular embolization
510(k) Number K171862
Device Name GALAXY G3 Mini Microcoil Delivery System
Applicant
Codman & Shurtleff, Inc
325 Paramount Drive
Raynham,  MA  02767
Applicant Contact Yoon Hee Beatty
Correspondent
Codman & Shurtleff, Inc
325 Paramount Drive
Raynham,  MA  02767
Correspondent Contact Yoon Hee Beatty
Regulation Number882.5950
Classification Product Code
HCG  
Subsequent Product Code
KRD  
Date Received06/22/2017
Decision Date 09/25/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-