TITANIUM POWERPORT ISP IMPLANTED PORT WITH 6 FR CHRONOFLEX POLYURETHANE CATHETER


Device Classification Name

port & catheter, implanted, subcutaneous, intravascular

510(k) Number K072549
Device Name TITANIUM POWERPORT ISP IMPLANTED PORT WITH 6 FR CHRONOFLEX POLYURETHANE CATHETER
Applicant
C.R. BARD, INC.
605 n 5600 w
salt lake city, 
UT 
84116

Applicant Contact susan d scott
Correspondent
C.R. BARD, INC.
605 n 5600 w
salt lake city, 
UT 
84116

Correspodent Contact susan d scott
Regulation Number 880.5965
Classification Product Code
LJT  
Date Received 09/10/2007
Decision Date 11/14/2007
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

No

Recalls CDRH Recalls