Device Classification Name |
stents, drains and dilators for the biliary ducts
|
510(k) Number |
K023870 |
Device Name |
FLEXIMA BILIARY CATHETER |
Applicant |
BOSTON SCIENTIFIC/MEDI-TECH |
ONE BOSTON SCIENTIFIC PLACE |
NATICK,
MA
01760 -1537
|
|
Applicant Contact |
NICHOLAS CONDAKES |
Correspondent |
BOSTON SCIENTIFIC/MEDI-TECH |
ONE BOSTON SCIENTIFIC PLACE |
NATICK,
MA
01760 -1537
|
|
Correspondent Contact |
NICHOLAS CONDAKES |
Regulation Number | 876.5010
|
Classification Product Code |
|
Date Received | 11/20/2002 |
Decision Date | 12/20/2002 |
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
|
Recalls |
CDRH Recalls
|
|
|