Device Classification Name |
Introducer, Catheter
|
510(k) Number |
K140543 |
Device Name |
PRELUDEEASE HYDROPHILIC SHEATH INTRODUCER |
Applicant |
MERIT MEDICAL SYSTEMS, INC. |
1600 WEST MERIT PKWY. |
SOUTH JORDAN,
UT
84095
|
|
Applicant Contact |
MICHAELA RIVKOWICH |
Correspondent |
MERIT MEDICAL SYSTEMS, INC. |
1600 WEST MERIT PKWY. |
SOUTH JORDAN,
UT
84095
|
|
Correspondent Contact |
MICHAELA RIVKOWICH |
Regulation Number | 870.1340
|
Classification Product Code |
|
Date Received | 03/04/2014 |
Decision Date | 10/16/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|