Device Classification Name |
Catheter, Percutaneous
|
510(k) Number |
K935292 |
Device Name |
SCHNEIDER GUIDEZILLA SOFTIP GUIDING CATHETER |
Applicant |
BOSTON SCIENTIFIC SCIMED, INC. |
5905 NATHAN LN. |
MINNEAPOLIS,
MN
55442
|
|
Applicant Contact |
JAMES C VANDER WYK |
Correspondent |
BOSTON SCIENTIFIC SCIMED, INC. |
5905 NATHAN LN. |
MINNEAPOLIS,
MN
55442
|
|
Correspondent Contact |
JAMES C VANDER WYK |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 11/02/1993 |
Decision Date | 06/10/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|