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

Device Classification Under Section 513(f)(2)(De Novo)
  • 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 tracheal prosthesis with cover material derived from human sources
De Novo Number DEN230087
Device Name AMStent® Tracheobronchial Covered Stent System
Requester
peytant solutions, inc.
3650 annapolis lane n., #180
plymouth,  MN  55447
Contact john schorgl
Regulation Number868.3721
Classification Product Code
SDB  
Date Received12/20/2023
Decision Date 10/16/2024
Decision granted (DENG)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Anesthesiology
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
-
-