Device Classification Name |
introducer, catheter
|
510(k) Number |
K140641 |
Device Name |
VESSIX GUIDE SHEATH 7F, 45 CM, RDC, VESSIX GUIDE SHEATH 7F, 45CM, LIMA |
Applicant |
Boston Scientific Corporation |
ONE SCIMED PLACE |
MAPLE GROVE,
MN
55311
|
|
Applicant Contact |
KURTIS HUNSBERGER |
Correspondent |
Boston Scientific Corporation |
ONE SCIMED PLACE |
MAPLE GROVE,
MN
55311
|
|
Correspondent Contact |
KURTIS HUNSBERGER |
Regulation Number | 870.1340
|
Classification Product Code |
|
Date Received | 03/12/2014 |
Decision Date | 07/03/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|