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, retention type, balloon
510(k) Number K002612
Device Name BARDEX I.C.PLUS FOLEY CATHETER WITH SILVER SALTS IN HYDROGEL COATING, MODEL 3CC BALLOON: 17008,170010,5CC BALLOON
Applicant
C.R. BARD, INC.
8195 INDUSTRIAL BLVD.
COVINGTON,  GA  30014
Applicant Contact GEORGIA C ABERNATHY
Correspondent
C.R. BARD, INC.
8195 INDUSTRIAL BLVD.
COVINGTON,  GA  30014
Correspondent Contact GEORGIA C ABERNATHY
Regulation Number876.5130
Classification Product Code
EZL  
Subsequent Product Code
KOD  
Date Received08/21/2000
Decision Date 09/03/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Abbreviated
Reviewed by Third Party No
Combination Product No
-
-