Device Classification Name |
Stents, Drains And Dilators For The Biliary Ducts
|
510(k) Number |
K900205 |
Device Name |
DRAINAGE CATHETERS W/A DISSOLVABLE TIP |
Applicant |
BOSTON SCIENTIFIC CORP. |
2710 ORCHARD PKWY. |
SAN JOSE,
CA
95134
|
|
Applicant Contact |
LEO L BASTA |
Correspondent |
BOSTON SCIENTIFIC CORP. |
2710 ORCHARD PKWY. |
SAN JOSE,
CA
95134
|
|
Correspondent Contact |
LEO L BASTA |
Regulation Number | 876.5010
|
Classification Product Code |
|
Date Received | 01/16/1990 |
Decision Date | 08/20/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|