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 K062671
Device Name 14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH HEPARIN COATING AND SILVER IMPREGNATED SLEEVE (PALINDROME SAPPHIRE)
Applicant
KENDALL
15 HAMPSHIRE ST.
MANSFIELD,  MA  02048
Applicant Contact KEITH MARTIN
Correspondent
KENDALL
15 HAMPSHIRE ST.
MANSFIELD,  MA  02048
Correspondent Contact KEITH MARTIN
Regulation Number876.5540
Classification Product Code
MSD  
Date Received09/08/2006
Decision Date 11/03/2006
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product Yes
Recalls CDRH Recalls
-
-