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

Premarket Approval (PMA)
  • 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
 
DevicePerQseal® Elite Vascular Closure Device
Generic NameDevice, hemostasis, vascular
ApplicantVivasure Medical , Ltd.
Parkmore Business Park W.
Galway H91 V3KP
PMA NumberP250015
Date Received06/16/2025
Decision Date10/16/2026
Product Code MGB 
Advisory Committee Cardiovascular
Clinical TrialsNCT04818541
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the PerQSeal Elite Vascular Closure Device. The device is indicated for the percutaneous closure of common femoral arteriotomies in patients following interventional endovascular catheterization procedures utilizing 14 – 22 F sheaths (arteriotomies up to 26 F).
-
-