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 K123338
Device Name BARRICADE EMBOLIZATION COIL SYSTEM
Applicant
BLOCKADE MEDICAL
18 Technology Dr Ste 169
Irvine,  CA  92618
Applicant Contact Rebecca K Pine
Correspondent
BLOCKADE MEDICAL
18 Technology Dr Ste 169
Irvine,  CA  92618
Correspondent Contact Rebecca K Pine
Regulation Number882.5950
Classification Product Code
HCG  
Date Received10/31/2012
Decision Date 03/28/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-