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 percutaneous catheter for creation of an arteriovenous fistula for hemodialysis access
De Novo Number DEN170004
Device Name Ellipsys Vascular Access System
Requester
Avenu Medical, Inc
27123 calle arroyo, suite 2101
san juan capistrano,  CA  92675
Contact rebecca k. pine
Regulation Number870.1252
Classification Product Code
PQK  
Date Received01/10/2017
Decision Date 06/22/2018
Decision granted (DENG)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Direct
-
-