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
|
|
Correspondent Contact |
BRIAN HAUGSTAD |
Regulation Number | 880.5965
|
Classification Product Code |
|
Subsequent Product Code |
|
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
|
Recalls |
CDRH Recalls
|
|
|