Device Classification Name |
dilator, catheter, ureteral
|
510(k) Number |
K933011 |
Device Name |
MICROVASIVE UROLOGICAL BALLOON DILATION CATHETER |
Applicant |
BOSTON SCIENTIFIC CORP. |
17425 N.E. UNION HILL RD. |
REDMOND,
WA
98052 -3376
|
|
Applicant Contact |
LORRAINE HANLEY |
Correspondent |
BOSTON SCIENTIFIC CORP. |
17425 N.E. UNION HILL RD. |
REDMOND,
WA
98052 -3376
|
|
Correspondent Contact |
LORRAINE HANLEY |
Regulation Number | 876.5470
|
Classification Product Code |
|
Date Received | 06/21/1993 |
Decision Date | 02/01/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|