VITALCARE FOLEY CATHETER


Device Classification Name

catheter, retention type, balloon

510(k) Number K021939
Device Name VITALCARE FOLEY CATHETER
Original Applicant
VITALCARE, INC.
15800 nw 13th ave.
miami, 
FL 
33169

Original Contact michael mcavenia
Regulation Number 876.5130
Classification Product Code
EZL  
Date Received 06/12/2002
Decision Date 04/22/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No