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 intravenous catheter force-activated separation device.
De Novo Number DEN190043
Device Name SafeBreak Vascular
Requester
site saver, inc. d/b/a lineus medical
179 n. church ave., suite 202
fayetteville,  AR  72701
Contact lemuel v. clement
Regulation Number880.5220
Classification Product Code
QOI  
Date Received09/18/2019
Decision Date 05/27/2021
Decision granted (DENG)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
-
-