CXI TRIFORCE


Device Classification Name

catheter, continuous flush

510(k) Number K111263
Device Name CXI TRIFORCE
Applicant
COOK INCORPORATED
750 daniels way
bloomington, 
IN 
47404

Applicant Contact molly busenbark
Correspondent
COOK INCORPORATED
750 daniels way
bloomington, 
IN 
47404

Correspodent Contact molly busenbark
Regulation Number 870.1210
Classification Product Code
KRA  
Date Received 05/04/2011
Decision Date 07/25/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No