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 Pancreatic Stent, Covered, Metallic, Removable
510(k) Number K152572
FOIA Releasable 510(k) K152572
Device Name AXIOS Stent and Delivery System
Applicant
Boston Scientific Corporation
453 Ravendale Dr., Suite H
Mountain View,  CA  94043
Applicant Contact ASHLEY SANTOS
Correspondent
Boston Scientific Corporation
453 Ravendale Dr., Suite H
Mountain View,  CA  94043
Correspondent Contact ASHLEY SANTOS
Regulation Number876.5015
Classification Product Code
PCU  
Date Received09/09/2015
Decision Date 10/06/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-