LIFESITE HEMODIALYSIS ACCESS SYSTEM, CANNULA EXCHANGE KIT, INSERTION KIT, ACCESS CANNILA


Device Classification Name

catheter, hemodialysis, implanted

510(k) Number K023023
Device Name LIFESITE HEMODIALYSIS ACCESS SYSTEM, CANNULA EXCHANGE KIT, INSERTION KIT, ACCESS CANNILA
Original Applicant
VASCA, INC.
3 highwood dr.
tewksbury, 
MA 
01876

Original Contact nama doddi
Regulation Number 876.5540
Classification Product Code
MSD  
Date Received 09/11/2002
Decision Date 12/04/2003
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