Device Classification Name |
port & catheter, implanted, subcutaneous, intravascular
|
510(k) Number |
K982888 |
Device Name |
VAXCEL IMPANTABLE VASCULAR ACCESS SYSTEM |
Applicant |
BOSTON SCIENTIFIC CORP. |
One Boston Scientific Place |
Natick,
MA
01760
|
|
Applicant Contact |
CHRISTINE M HARRIS |
Correspondent |
BOSTON SCIENTIFIC CORP. |
One Boston Scientific Place |
Natick,
MA
01760
|
|
Correspondent Contact |
CHRISTINE M HARRIS |
Regulation Number | 880.5965
|
Classification Product Code |
|
Date Received | 08/17/1998 |
Decision Date | 10/20/1998 |
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
|
|
|