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 K133310
Device Name AXIUM DETACHABLE COIL SYSTEM
Applicant
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
9775 Toledo Way
Lrvine,  CA  92618
Applicant Contact ANGELA LAMPREY
Correspondent
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
9775 Toledo Way
Lrvine,  CA  92618
Correspondent Contact ANGELA LAMPREY
Regulation Number882.5950
Classification Product Code
HCG  
Subsequent Product Code
KRD  
Date Received10/28/2013
Decision Date 01/10/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-