Device Classification Name |
port & catheter, implanted, subcutaneous, intravascular
|
510(k) Number |
K964538 |
Device Name |
R-PORT STANDARD IMPLANTABLE VASCULAR ACCESS SYSTEM |
Applicant |
BOSTON SCIENTIFIC CORP. |
ONE BOSTON SCIENTIFIC PL. |
NATICK,
MA
01760 -1537
|
|
Applicant Contact |
WANDA M CARPINELLA |
Correspondent |
BOSTON SCIENTIFIC CORP. |
ONE BOSTON SCIENTIFIC PL. |
NATICK,
MA
01760 -1537
|
|
Correspondent Contact |
WANDA M CARPINELLA |
Regulation Number | 880.5965
|
Classification Product Code |
|
Date Received | 11/12/1996 |
Decision Date | 03/10/1997 |
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
|
|
|