The following data is part of a premarket notification filed by Merit Medical Systems, Inc with the FDA for Fountain Valvetip Infusion Catheter.
| Device ID | K193082 |
| 510k Number | K193082 |
| Device Name: | Fountain ValveTip Infusion Catheter |
| Classification | Catheter, Continuous Flush |
| Applicant | Merit Medical Systems, Inc 1600 West Merit Parkway South Jordan, UT 84095 |
| Contact | Spriha Pandey |
| Correspondent | Spriha Pandey Merit Medical Systems, Inc 1600 West Merit Parkway South Jordan, UT 84095 |
| Product Code | KRA |
| CFR Regulation Number | 870.1210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-05 |
| Decision Date | 2020-08-07 |