Device Classification Name |
Port & Catheter, Implanted, Subcutaneous, Intravascular
|
510(k) Number |
K062414 |
Device Name |
VORTEX CT PORT ACCESS SYSTEM AND LIFEGUARD SAFETY INFUSION SET |
Applicant |
RITA MEDICAL SYSTEMS, INC. |
ONE HORIZON WAY |
MANCHESTER,
GA
31816
|
|
Applicant Contact |
DAVID SMITH |
Correspondent |
RITA MEDICAL SYSTEMS, INC. |
ONE HORIZON WAY |
MANCHESTER,
GA
31816
|
|
Correspondent Contact |
DAVID SMITH |
Regulation Number | 880.5965
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/17/2006 |
Decision Date | 02/01/2007 |
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
|
|
|