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 K140273
Device Name EQUALIZER OCCLUSION BALLOON CATHETER
Applicant
Boston Scientific Corp
One Scimed Place
Maple Grove,  MN  55311 -1566
Applicant Contact DIANE NELSON
Correspondent
Boston Scientific Corp
One Scimed Place
Maple Grove,  MN  55311 -1566
Correspondent Contact DIANE NELSON
Regulation Number870.4450
Classification Product Code
MJN  
Date Received02/03/2014
Decision Date 07/22/2014
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
-
-