The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Merit Marquis Flow Switch.
Device ID | K110643 |
510k Number | K110643 |
Device Name: | MERIT MARQUIS FLOW SWITCH |
Classification | Catheter, Intravascular, Diagnostic |
Applicant | MERIT MEDICAL SYSTEMS, INC. PARKMORE BUSINESS PARK WEST Galway, IE Ei |
Contact | Mark Mullaney |
Correspondent | Mark Mullaney MERIT MEDICAL SYSTEMS, INC. PARKMORE BUSINESS PARK WEST Galway, IE Ei |
Product Code | DQO |
CFR Regulation Number | 870.1200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-03-04 |
Decision Date | 2011-07-01 |
Summary: | summary |