• 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 K150319
Device Name MICRUSFRAME 10/18, DELTAFILL 18, DELTAXSFT 10, GALAXY G3 FILL/XSFT STRETCH RESISTANT MICROCOIL DELIVERY SYSTEMS
Applicant
CODMAN & SHURTLEFF, INC.
325 paramount dr.
raynham,  MA  02767
Applicant Contact hannah foley
Correspondent
CODMAN & SHURTLEFF, INC.
325 paramount dr.
raynham,  MA  02767
Correspodent Contact hannah foley
Regulation Number882.5950
Classification Product Code
HCG  
Subsequent Product Code
KRD  
Date Received02/09/2015
Decision Date 06/12/2015
Decision substantially equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-