HeRO Graft
FDA 510(k) clearance K213845 · decided 2022-08-15
Clearance details
- K-number
- K213845
- Device name
- HeRO Graft
- Applicant
- Merit Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2021-12-09
- Decision date
- 2022-08-15
- Days to decision
- 249 days
- Clearance type
- Traditional
- Product code
- DSY
- Device class
- 2
- Regulation number
- 870.3450
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- South Jordan, UT, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Fusion Bioline Vascular Graft (K252445) | Maquet Cardiovascular, LLC | 2026-04-27 |
| Spiral Laminar Flow™ Vascular Arteriovenous Graft (AV0645) (K252277) | Vascular Flow Technologies Limited | 2025-10-20 |
| Gelweave™ Vascular Prostheses (K241550) | Vascutek, Ltd. | 2025-02-27 |
| Gelsoft™ Plus Vascular Prostheses (K241070) | Vascutek, Ltd. | 2024-11-15 |
| Advanta VXT Vascular Graft, Flixene Vascular Graft (K231972) | Atrium Medical Corporation | 2024-03-28 |
| GORE® PROPATEN® Vascular Graft (K240083) | W. L. Gore & Associates, Inc. | 2024-03-01 |
| exGraft ePTFE Vascular Grafts, exGraft Carbon ePTFE Vascular Grafts (K233783) | Peca Labs, Inc. | 2024-01-17 |
| GORE® PROPATEN® Vascular Graft (K232312) | W. L. Gore & Associates, Inc. | 2024-01-09 |
| GORE® ACUSEAL Vascular Graft (K233551) | W. L. Gore & Associates, Inc. | 2023-12-19 |
| GORE® ACUSEAL Vascular Graft (K231505) | W. L. Gore & Associates, Inc. | 2023-06-23 |
| exGraft, exGraft Carbon (K221628) | Peca Labs | 2022-08-04 |
| HeRO Graft, HeRO Adapter (K203724) | Merit Medical Systems, Inc. | 2021-05-25 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| WRAPSODY® Cell-Impermeable Endoprosthesis (P240023/S004) | Merit Medical Systems, Inc. | 2025-12-11 |
| WRAPSODY Cell-Impermeable Endoprosthesis (P240023/S001) | Merit Medical Systems, Inc. | 2025-02-12 |
| WRAPSODY Cell-Impermeable Endoprosthesis (P240023/S002) | Merit Medical Systems, Inc. | 2025-02-12 |
| WRAPSODY® Cell-Impermeable Endoprosthesis (P240023) | Merit Medical Systems, Inc. | 2024-12-19 |