Device Classification Name |
Introducer, Catheter
|
510(k) Number |
K150257 |
Device Name |
PreludeEASE Hydrophilic Sheath Introducer |
Applicant |
Merit Medical Systems, Inc. |
1600 West Merit Parkway |
South Jordan,
UT
84095
|
|
Applicant Contact |
Michaela Rivkowich |
Correspondent |
Merit Medical Systems, Inc. |
1600 West Merit Parkway |
South Jordan,
UT
84095
|
|
Correspondent Contact |
Michaela Rivkowich |
Regulation Number | 870.1340
|
Classification Product Code |
|
Date Received | 02/03/2015 |
Decision Date | 06/19/2015 |
Decision |
Substantially Equivalent - Kit
(SESK) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|