AC 3 LUMEN CENTRAL VENOUS ACCESS KIT WITH ARROWG+ARD ANTIMICROBIAL SURFACE

Device Classification Name

catheter,intravascular,therapeutic,short-term less than 30 days

510(k) Number K032962
Device Name AC 3 LUMEN CENTRAL VENOUS ACCESS KIT WITH ARROWG+ARD ANTIMICROBIAL SURFACE
Applicant
ARROW INTL., INC.
2400 bernville rd.
reading, 
PA 
19605

Applicant Contact elizabeth price
Correspondent
ARROW INTL., INC.
2400 bernville rd.
reading, 
PA 
19605

Correspodent Contact elizabeth price
Regulation Number 880.5200
Classification Product Code
FOZ  
Subsequent Product Code
DYB  
Date Received 09/23/2003
Decision Date 10/29/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

Yes