Device Classification Name |
Port & Catheter, Implanted, Subcutaneous, Intravascular
|
510(k) Number |
K010767 |
Device Name |
LIFEPORT VTX ACCESS SYSTEM,MODEL VTX 7000 SERIES |
Applicant |
HORIZON MEDICAL PRODUCTS, INC. |
1 HORIZON WAY |
MANCHESTER,
GA
31816
|
|
Applicant Contact |
PENNY M NORTHCUTT |
Correspondent |
HORIZON MEDICAL PRODUCTS, INC. |
1 HORIZON WAY |
MANCHESTER,
GA
31816
|
|
Correspondent Contact |
PENNY M NORTHCUTT |
Regulation Number | 880.5965
|
Classification Product Code |
|
Date Received | 03/14/2001 |
Decision Date | 04/10/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|