Device Classification Name |
catheter, hemodialysis, implanted
|
510(k) Number |
K012365 |
Device Name |
VAXCEL DIALYSIS CATHETER |
Applicant |
BOSTON SCIENTIFIC CORP. |
One Boston Scientific Place |
Natick,
MA
01760
|
|
Applicant Contact |
NICHOLAS CONDAKES |
Correspondent |
BOSTON SCIENTIFIC CORP. |
One Boston Scientific Place |
Natick,
MA
01760
|
|
Correspondent Contact |
NICHOLAS CONDAKES |
Regulation Number | 876.5540
|
Classification Product Code |
|
Date Received | 07/26/2001 |
Decision Date | 08/24/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|