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 K002902
Device Name TANDEM-CATH 10 FR. CATHETER SYSTEM, MODEL MULTIPLE CODE NUMBERS
Applicant
THE KENDALL COMPANY
15 HAMPSHIRE ST.
MANSFIELD,  MA  02048
Applicant Contact FRANK J FUCILE
Correspondent
THE KENDALL COMPANY
15 HAMPSHIRE ST.
MANSFIELD,  MA  02048
Correspondent Contact FRANK J FUCILE
Regulation Number876.5540
Classification Product Code
MSD  
Date Received09/18/2000
Decision Date 04/09/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-