Device Classification Name |
port & catheter, implanted, subcutaneous, intravascular
|
510(k) Number |
K070116 |
Device Name |
POWER PORT-A-CATH AND POWER PORT-A-CATH II; IMPLANTABLE VENOUS ACCESS SYSTEMS AND POWER GRIPPER PLUS NEEDLE |
Applicant |
SMITHS MEDICAL MD, INC. |
1265 GREY FOX RD. |
ST. PAUL,
MN
55112
|
|
Applicant Contact |
PHIL NEURURER |
Correspondent |
SMITHS MEDICAL MD, INC. |
1265 GREY FOX RD. |
ST. PAUL,
MN
55112
|
|
Correspondent Contact |
PHIL NEURURER |
Regulation Number | 880.5965
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 01/12/2007 |
Decision Date | 05/23/2007 |
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
|
|
|