Device Classification Name |
catheter, intravascular, diagnostic
|
510(k) Number |
K110643 |
Device Name |
MERIT MARQUIS FLOW SWITCH |
Applicant |
MERIT MEDICAL SYSTEMS, INC. |
PARKMORE BUSINESS PARK WEST |
GALWAY,
IE
EI
|
|
Applicant Contact |
MARK MULLANEY |
Correspondent |
MERIT MEDICAL SYSTEMS, INC. |
PARKMORE BUSINESS PARK WEST |
GALWAY,
IE
EI
|
|
Correspondent Contact |
MARK MULLANEY |
Regulation Number | 870.1200
|
Classification Product Code |
|
Date Received | 03/04/2011 |
Decision Date | 07/01/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|