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 system, peritoneal, automatic delivery
510(k) Number K212658
Device Name CloudCath Peritoneal Dialysis Drain Set Monitoring System
Applicant
CloudCath
665 3rd Street, Suite 250
San Francisco,  CA  94107
Applicant Contact Brian Fisher
Correspondent
CloudCath
665 3rd Street, Suite 250
San Francisco,  CA  94107
Correspondent Contact Brian Fisher
Regulation Number876.5630
Classification Product Code
FKX  
Date Received08/23/2021
Decision Date 02/09/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Clinical Trials NCT04515498
Reviewed by Third Party No
Combination Product No
-
-