The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Ventrax Delivery System.
| Device ID | K202610 |
| 510k Number | K202610 |
| Device Name: | Ventrax Delivery System |
| Classification | Catheter, Percutaneous |
| Applicant | Merit Medical Systems, Inc. 1600 West Merit Parkway South Jordan, UT 84095 |
| Contact | Elizabeth Lazaro |
| Correspondent | Elizabeth Lazaro Merit Medical Systems, Inc. 65 Great Valley Parkway Malvern, PA 19355 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-09 |
| Decision Date | 2020-12-14 |
| Summary: | summary |