DIATEK CANNON-CATHETER, MODEL CC5500


Device Classification Name

catheter, hemodialysis, implanted

510(k) Number K022662
Device Name DIATEK CANNON-CATHETER, MODEL CC5500
Original Applicant
ARROW INTL., INC.
2400 bernville rd.
reading, 
PA 
19605

Original Contact thomas nickel
Regulation Number 876.5540
Classification Product Code
MSD  
Date Received 08/09/2002
Decision Date 05/09/2003
Decision

substantially equivalent – kit

(SESK)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No