Device Classification Name |
Introducer, Catheter
|
510(k) Number |
K132720 |
Device Name |
HEARTSPAN FIXED CURVE BRAIDED TRANSSEPTAL SHEATH |
Applicant |
MERIT MEDICAL SYSTEMS, INC. |
65 GREAT VALLEY PAKRWAY |
MALVERN,
PA
19355
|
|
Applicant Contact |
ALINA STUBBS |
Correspondent |
MERIT MEDICAL SYSTEMS, INC. |
65 GREAT VALLEY PAKRWAY |
MALVERN,
PA
19355
|
|
Correspondent Contact |
ALINA STUBBS |
Regulation Number | 870.1340
|
Classification Product Code |
|
Date Received | 08/30/2013 |
Decision Date | 02/12/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|