• 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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name catheter, retention type, balloon
510(k) Number K003289
Device Name BARDEX LATEX-FREE TEMPERATURE-SENSING FOLEY CATHETER (UNCOATED); BARDEX LUBRI-SIL TEMPERATURE-SENSING FOLEY CATHETER (LU
Original Applicant
C.R. BARD, INC.
8195 industrial blvd.
covington,  GA  30014
Original Contact george c abernathy
Regulation Number876.5130
Classification Product Code
EZL  
Subsequent Product Code
MJC  
Date Received10/20/2000
Decision Date 01/05/2001
Decision substantially equivalent (SE)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee Gastroenterology/Urology
summary summary
Type Abbreviated
Reviewed by Third Party Yes
Expedited Review No
Combination Product No
-
-