The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Concierge Guiding Catheter.
| Device ID | K121051 |
| 510k Number | K121051 |
| Device Name: | CONCIERGE GUIDING CATHETER |
| Classification | Catheter, Percutaneous |
| Applicant | MERIT MEDICAL SYSTEMS, INC. 1111 South Velasco St Angleton, TX 77515 |
| Contact | Michaela Rivkowich |
| Correspondent | Michaela Rivkowich MERIT MEDICAL SYSTEMS, INC. 1111 South Velasco St Angleton, TX 77515 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-06 |
| Decision Date | 2012-06-13 |
| Summary: | summary |