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, Implanted
510(k) Number K130851
Device Name CASCADE HEMODIALYSIS/APHERESIS CATHETER
Applicant
Health Line International Corporation
803 N. 1250 W.
Suite 1
Centerville,  UT  84014
Applicant Contact NOLA BENSTOG
Correspondent
Health Line International Corporation
803 N. 1250 W.
Suite 1
Centerville,  UT  84014
Correspondent Contact NOLA BENSTOG
Regulation Number876.5540
Classification Product Code
MSD  
Date Received03/27/2013
Decision Date 01/09/2014
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-