Device Classification Name |
introducer, catheter
|
510(k) Number |
K230051 |
Device Name |
14F iSLEEVE™ Introducer Set |
Applicant |
Boston Scientific Corporation |
One Scimed Place |
Maple Grove,
MN
55311
|
|
Applicant Contact |
Kendall Lindenman |
Correspondent |
Boston Scientific Corporation |
One Scimed Place |
Maple Grove,
MN
55311
|
|
Correspondent Contact |
Kendall Lindenman |
Regulation Number | 870.1340
|
Classification Product Code |
|
Date Received | 01/06/2023 |
Decision Date | 02/03/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|