• 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
510(k) Number K010778
Device Name NIAGARA SLIM-CATH
Applicant
C.R. BARD, INC.
5425 WEST AMELIA EARHART DR.
salt lake city,  UT  84116
Applicant Contact peggy keiffer
Correspondent
C.R. BARD, INC.
5425 WEST AMELIA EARHART DR.
salt lake city,  UT  84116
Correspondent Contact peggy keiffer
Regulation Number876.5540
Classification Product Code
MPB  
Date Received03/15/2001
Decision Date 04/13/2001
Decision substantially equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Special
Reviewed by Third Party No
Combination Product No
-
-