Device Classification Name |
introducer, catheter
|
510(k) Number |
K152381 |
Device Name |
Prelude SNAP Splittable Hydrophilic Sheath Introducer |
Applicant |
MERIT MEDICAL SYSTEMS, INC. |
65 GREAT VALLEY PARKWAY |
MALVERN,
PA
19355
|
|
Applicant Contact |
Alina Stubbs |
Correspondent |
MERIT MEDICAL SYSTEMS, INC. |
65 GREAT VALLEY PARKWAY |
MALVERN,
PA
19355
|
|
Correspondent Contact |
Alina Stubbs |
Regulation Number | 870.1340
|
Classification Product Code |
|
Date Received | 08/24/2015 |
Decision Date | 10/30/2015 |
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
|
|
|