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, Hemodialysis, Non-Implanted, Ultrafiltration, For Peripheral Use
510(k) Number K252226
Device Name Dual Lumen Extended Length Catheter (dELC), 6F, 12cm (320101); Dual Lumen Extended Length Catheter (dELC), 6F, 16 cm (320102)
Applicant
Nuwellis, Inc.
12988 Valley View Rd.
Eden Prairie,  MN  55344
Applicant Contact Neil Ayotte
Correspondent
Avio Medtech Consulting
2300 Myrtle Ave. Suite 200
St. Paul,  MN  55114
Correspondent Contact Sydney Wiggins
Regulation Number876.5540
Classification Product Code
NQJ  
Subsequent Product Code
MPB  
Date Received07/16/2025
Decision Date 08/13/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-