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 |