The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Hero Graft, Hero Adapter.
| Device ID | K203724 |
| 510k Number | K203724 |
| Device Name: | HeRO Graft, HeRO Adapter |
| Classification | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter |
| Applicant | Merit Medical Systems, Inc. 1600 West Merit Parkway South Jordan, UT 84095 |
| Contact | Susan Christensen |
| Correspondent | Susan Christensen Merit Medical Systems, Inc. 1600 West Merit Parkway South Jordan, UT 84095 |
| Product Code | DSY |
| Subsequent Product Code | LJS |
| Subsequent Product Code | MSD |
| CFR Regulation Number | 870.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-21 |
| Decision Date | 2021-05-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884450415273 | K203724 | 000 |