The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Hero Graft.
| Device ID | K213845 |
| 510k Number | K213845 |
| Device Name: | HeRO Graft |
| 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 | 2021-12-09 |
| Decision Date | 2022-08-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884450564315 | K213845 | 000 |
| 00884450564301 | K213845 | 000 |
| 00884450563922 | K213845 | 000 |
| 00884450563915 | K213845 | 000 |
| 00884450564363 | K213845 | 000 |
| 10884450564322 | K213845 | 000 |