Device Classification Name |
introducer, catheter
|
510(k) Number |
K211405 |
Device Name |
Prelude Guide Sheath |
Applicant |
Merit Medical Systems, Inc. |
1600 West Merit Parkway |
South Jordan,
UT
84095
|
|
Applicant Contact |
David Thomas |
Correspondent |
Merit Medical Systems, Inc. |
1600 West Merit Parkway |
South Jordan,
UT
84095
|
|
Correspondent Contact |
David Thomas |
Regulation Number | 870.1340
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/06/2021 |
Decision Date | 10/04/2021 |
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
|
|
|