Device Classification Name |
introducer, catheter
|
510(k) Number |
K172117 |
Device Name |
Prelude Pursuit Splittable Sheath Introducer |
Applicant |
Merit Medical Systems, Inc. |
65 Great Valley Parkway |
Malvern,
PA
19355
|
|
Applicant Contact |
Jacquelyn Huyghue |
Correspondent |
Merit Medical Systems, Inc. |
65 Great Valley Parkway |
Malvern,
PA
19355
|
|
Correspondent Contact |
Jacquelyn Huyghue |
Regulation Number | 870.1340
|
Classification Product Code |
|
Date Received | 07/13/2017 |
Decision Date | 09/11/2017 |
Decision |
Substantially Equivalent - Kit
(SESK) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|