COOK VASCULAR INC. VITAL-PORT VASCULAR ACCESS SYSTEM POWER INJECTABLE PORT


Device Classification Name

port & catheter, implanted, subcutaneous, intravascular

510(k) Number K081425
Device Name COOK VASCULAR INC. VITAL-PORT VASCULAR ACCESS SYSTEM POWER INJECTABLE PORT
Applicant
COOK VASCULAR, INC.
1186 montgomery lane
vandergrift, 
PA 
15690

Applicant Contact jim ferguson
Correspondent
COOK VASCULAR, INC.
1186 montgomery lane
vandergrift, 
PA 
15690

Correspodent Contact jim ferguson
Regulation Number 880.5965
Classification Product Code
LJT  
Date Received 05/21/2008
Decision Date 09/30/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No