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 Catheter, Intravascular Occluding, Temporary
510(k) Number K142692
Device Name Occlusion Balloon Catheter
Applicant
Embolx, Inc.
5760 Arboretum Dr.
Los Altos,  CA  94024
Applicant Contact Michael P Allen
Correspondent
Coombs Medical Device Consulting
1193 Sherman St.
Alameda,  CA  94501
Correspondent Contact Craig J Coombs
Regulation Number870.4450
Classification Product Code
MJN  
Date Received09/22/2014
Decision Date 05/31/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-