510(k) K032900
- Device
- LIFESPAN REINFORCED EPTFE STRAIGHT VASCULAR GRAFTS, EXTERNALLY SUPPORTED VASCULAR GRAFTS, STEPPED VASCULAR GRAFTS
- Applicant
- EDWARDS LIFESCIENCES, LLC.
- 510(k) number
- K032900
- Product code
- DSY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-12-04
- Date received
- 2003-09-17
- Regulation
- 870.3450
- Classification name
- Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Daun Putnam
- Address
- One Edwards Way Irvine CA US 92614 92614
FDA Registration Numbers#
- 3006950086
- 1220477
- 2242352
- 3007676031
- 3033589330
- 1721676
- 1720929
- 1721504
- 1724474
- 1018233
- 2017233
- 9612515
- 1640201
- 1220948
- 3013718163
- 2246552
- 3012536737
- 1723241
- 3010407203
- 3015225571
- 3011175548
- 3010097171
- 2020394
- 3010162973
- 3015309643
- 3006082230
Source Documents#
Other 510(k) Records For Product Code DSY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252445 | Fusion Bioline Vascular Graft | Maquet Cardiovascular, LLC | 2026-04-27 |
| K252277 | Spiral Laminar Flow™ Vascular Arteriovenous Graft (AV0645) | Vascular Flow Technologies Limited | 2025-10-20 |
| K241550 | Gelweave™ Vascular Prostheses | Vascutek, Ltd. | 2025-02-27 |
| K241070 | Gelsoft™ Plus Vascular Prostheses | Vascutek, Ltd. | 2024-11-15 |
| K231972 | Advanta VXT Vascular Graft, Flixene Vascular Graft | Atrium Medical Corporation | 2024-03-28 |
| K240083 | GORE® PROPATEN® Vascular Graft | W. L. Gore & Associates, Inc. | 2024-03-01 |
| K233783 | exGraft ePTFE Vascular Grafts, exGraft Carbon ePTFE Vascular Grafts | Peca Labs, Inc. | 2024-01-17 |
| K232312 | GORE® PROPATEN® Vascular Graft | W. L. Gore & Associates, Inc. | 2024-01-09 |
| K233551 | GORE® ACUSEAL Vascular Graft | W. L. Gore & Associates, Inc. | 2023-12-19 |
| K231505 | GORE® ACUSEAL Vascular Graft | W. L. Gore & Associates, Inc. | 2023-06-23 |
| K213845 | HeRO Graft | Merit Medical Systems, Inc. | 2022-08-15 |
| K221628 | exGraft, exGraft Carbon | Peca Labs | 2022-08-04 |
| K203724 | HeRO Graft, HeRO Adapter | Merit Medical Systems, Inc. | 2021-05-25 |
| K202703 | Vascutek Gelsoft Plus ERS Vascular Graft | Vascutek, Ltd. | 2021-04-06 |
| K202471 | exGraft ePTFE Vascular Graft, exGraft Carbon ePTFE Vascular Graft | Peca Labs | 2020-12-11 |
Legacy Summary#
summary
FDA Review#
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