Device Classification Name |
Catheter, Percutaneous
|
510(k) Number |
K980453 |
Device Name |
SCHNEIDER GUIDER SOFTIP GUIDING CATHETERS |
Applicant |
BOSTON SCIENTIFIC SCIMED, INC. |
5905 NATHAN LN. |
MINNEAPOLIS,
MN
55442
|
|
Applicant Contact |
RON BENNETT |
Correspondent |
BOSTON SCIENTIFIC SCIMED, INC. |
5905 NATHAN LN. |
MINNEAPOLIS,
MN
55442
|
|
Correspondent Contact |
RON BENNETT |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 02/05/1998 |
Decision Date | 08/11/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|