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 peripheral temporary and retrievable stent system
De Novo Number DEN240048
Device Name Spur Peripheral Retrievable Stent System
Requester
reflow medical, inc.
208 avenida fabricante, suite 100
san clemente,  CA  92672
Contact lori grace
Regulation Number870.5110
Classification Product Code
SEU  
Date Received09/20/2024
Decision Date 05/29/2025
Decision granted (DENG)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
Type Direct
Predetermined Change
Control Plan Authorized		 No
-
-