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

510(k) Premarket Notification
  • 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 Catheter, Continuous Flush
510(k) Number K250794
Device Name InVera Infusion Device
Applicant
Invera Medical
Unit 113, Innovation Hub,
Dublin Rd.,
Galway,  IE H91 DCH9
Applicant Contact Nigel Phelan
Correspondent
Invera Medical
Unit 113, Innovation Hub,
Dublin Rd.,
Galway,  IE H91 DCH9
Correspondent Contact Nigel Phelan
Regulation Number870.1210
Classification Product Code
KRA  
Date Received03/14/2025
Decision Date 03/12/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-