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 Balloon Aortic Valvuloplasty
510(k) Number K142199
Device Name Ascendra Balloon Aortic Valvaloplasty Catheter
Applicant
Edwards Lifesciences
One Edwards Way
Irvine,  CA  92614
Applicant Contact Susan Reynolds
Correspondent
Edwards Lifesciences
One Edwards Way
Irvine,  CA  92614
Correspondent Contact Susan Reynolds
Regulation Number870.1255
Classification Product Code
OZT  
Date Received08/11/2014
Decision Date 10/29/2014
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
-
-