POWER PORT-A-CATH, CATH II, AND P.A.S. PORT T2 POWER P.A.C. IMPLANTABLE VENOUS ACCESS SYSTEMS AND POWER GRIPPER PLUS


Device Classification Name

port & catheter, implanted, subcutaneous, intravascular

510(k) Number K072657
Device Name POWER PORT-A-CATH, CATH II, AND P.A.S. PORT T2 POWER P.A.C. IMPLANTABLE VENOUS ACCESS SYSTEMS AND POWER GRIPPER PLUS
Applicant
SMITHS MEDICAL MD, INC.
1265 grey fox rd.
arden hills, 
MN 
55112

Applicant Contact brian haugstad
Correspondent
SMITHS MEDICAL MD, INC.
1265 grey fox rd.
arden hills, 
MN 
55112

Correspodent Contact brian haugstad
Regulation Number 880.5965
Classification Product Code
LJT  
Subsequent Product Code
FPA  
Date Received 09/20/2007
Decision Date 12/14/2007
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