NIAGARA TEMPORARY DUAL LUMEN CATHETERS; FLEXXICON II TEMPORARY DUAL LUMEN CATHETERS


Device Classification Name

catheter, hemodialysis, non-implanted

510(k) Number K030268
Device Name NIAGARA TEMPORARY DUAL LUMEN CATHETERS; FLEXXICON II TEMPORARY DUAL LUMEN CATHETERS
Original Applicant
C.R. BARD, INC.
5425 west amelia earhart dr.
salt lake city, 
UT 
84116

Original Contact glenn norton
Regulation Number 876.5540
Classification Product Code
MPB  
Date Received 01/27/2003
Decision Date 07/30/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No