Product code DSY
- Device name
- Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.3450
- Review panel
- CV
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P840029S014 | HEMASHIELD(R) MICROVEL (R) DOUBLE VELOUR GRAFT | Maquet Cardiovascular, LLC | 1993-05-17 |
| P840029S007 | HEMASHIELD WOVEN DOUBLE VELOUR GRAFTS 7MMX100CM | Maquet Cardiovascular, LLC | 1993-05-17 |
| P840029S006 | HEMASHIELD WOVEN DOUBLE VELOUR GRAFTS 12 X 6MM | Maquet Cardiovascular, LLC | 1993-05-17 |
| P840029S004 | HEMASHIELD ETS(TM) FLANGED GRAFT | Maquet Cardiovascular, LLC | 1993-05-17 |
| P840029S015 | HEMASHIELD(R) WOVEN DOUBLE VELOUR GRAFT | Maquet Cardiovascular, LLC | 1993-05-11 |
| P840029S010 | HEMASHIELD WOVEN DOUBLE VELOUR GRAFTS | Maquet Cardiovascular, LLC | 1993-05-11 |
| P840029S009 | HEMASHIELD WOVEN DOUBLE VELOUR GRAFTS | Maquet Cardiovascular, LLC | 1993-05-11 |
| P840029S008 | HEMASHIELD WOVEN DOUBLE VELOUR GRAFTS 7MMX100CM | Maquet Cardiovascular, LLC | 1993-05-11 |
| P840029S005 | HEMASHIELD WOVEN DOUBLE VELOUR GRAFTS | Maquet Cardiovascular, LLC | 1993-05-11 |
| P840029S002 | MICROVEL(R) WITH HEMASHIELD | Maquet Cardiovascular, LLC | 1990-07-18 |
| P840029 | MICROVEL(R) WITH HEMASHIELD | Maquet Cardiovascular, LLC | 1989-04-26 |
Related 510(k) Records#
| 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 |
| K183613 | exGraft, exGraft Carbon | Peca Labs | 2019-04-22 |
| K180957 | exGraft, exGraft Carbon ePTFE Vascular Grafts | Peca Labs | 2018-08-21 |
| K172637 | HeRO Graft | Merit Medical Systems, Inc. | 2017-11-30 |
| K162803 | Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular Grafts | Vascutek, Ltd. | 2017-07-14 |
| K162794 | Gelweave Vascular Grafts | Vascutek, Ltd. | 2017-06-30 |
| K153523 | FUSION Vascular Graft | Maquet Cardiovascular, LLC | 2016-02-16 |
| K150389 | Spiral Flow Peripheral Vascular Graft | Vascular Flow Technologies, Ltd. | 2015-05-06 |
| K142062 | SPIRAL FLOW PERIPHERAL VASCULAR GRAFT | Vascular Flow Technologies, Ltd. | 2014-11-20 |
| K141124 | SPIRAL FLOW VASCULAR ARTERIOVENOUS GRAFT | Vascular Flow Technologies, Ltd. | 2014-05-30 |
| K131778 | FUSION VASCULAR GRAFT AND FUSION BIOLINE VASCULAR GRAFT | Maquet Cardiovascular, LLC | 2013-11-14 |
| K130215 | GORE ACUSEAL VASCULAR GRAFT | W. L. Gore & Associates, Inc. | 2013-04-09 |
| K130142 | FLIXENE IFG VASCULAR GRAFT | Atrium Medical Corporation | 2013-03-15 |
| K124039 | HERO GRAFT | Hemoshpere, Inc., A Cryolife Company | 2013-03-07 |
| K130016 | LIFESPAN EPTFE VASCULAR GRAFT | LeMaitre Vascular, Inc. | 2013-02-05 |
| K122138 | ATRIUM FLIXENE IFG VASCULAR GRAFT | Atrium Medical Corp. | 2012-08-17 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| B040AMGMSD1 | Anastomark Coronary Artery Bypass Graft Markers, Stainless Steel, Distal | GENESEE BIOMEDICAL, INC. | 2017-02-01 |
| B040FMPM11 | Anastomark Coronary Artery Bypass Graft Markers, Flexible Proximal | GENESEE BIOMEDICAL, INC. | 2017-02-01 |
| B040FMPM21 | Anastomark Coronary Artery Bypass Graft Markers, Flexible Proximal | GENESEE BIOMEDICAL, INC. | 2017-02-01 |
| B040FMPM31 | Anastomark Coronary Artery Bypass Graft Markers, Flexible Proximal | GENESEE BIOMEDICAL, INC. | 2017-02-01 |
| B040AMGMPM1 | Anastomark Coronary Artery Bypass Graft Markers, Stainless Steel, Proximal, Med | GENESEE BIOMEDICAL, INC. | 2017-02-01 |
| 00384401016502 | GRAFT SIZERS | INTERVASCULAR SAS | 2016-06-24 |
| 00384401016519 | GRAFT SIZERS | INTERVASCULAR SAS | 2016-06-24 |
| 00650862220759 | ADVANTA SLIDER GDS | Atrium Medical Corporation | 2015-09-24 |
| 00650862222128 | ADVANTA SLIDER GDS | Atrium Medical Corporation | 2015-09-24 |
| 00650862220766 | ADVANTA SLIDER GDS | Atrium Medical Corporation | 2015-09-24 |
| 00650862220926 | ADVANTA SLIDER GDS | Atrium Medical Corporation | 2015-09-24 |
| 00650862221152 | ADVANTA SLIDER GDS | Atrium Medical Corporation | 2015-09-24 |
| 00650862221169 | ADVANTA SLIDER GDS | Atrium Medical Corporation | 2015-09-24 |
| 00650862221251 | ADVANTA SLIDER GDS | Atrium Medical Corporation | 2015-09-24 |
| 00650862221695 | ADVANTA SLIDER GDS | Atrium Medical Corporation | 2015-09-24 |
| 00650862221855 | ADVANTA SLIDER GDS | Atrium Medical Corporation | 2015-09-24 |
| 00650862221909 | ADVANTA SLIDER GDS | Atrium Medical Corporation | 2015-09-24 |
| 00650862221923 | ADVANTA SLIDER GDS | Atrium Medical Corporation | 2015-09-24 |
| 00650862220728 | ADVANTA SLIDER GDS | Atrium Medical Corporation | 2015-09-24 |
| 00650862220704 | ADVANTA SLIDER GDS | Atrium Medical Corporation | 2015-09-24 |
| 00650862220643 | ADVANTA SLIDER GDS | Atrium Medical Corporation | 2015-09-24 |
| 00650862220636 | ADVANTA SLIDER GDS | Atrium Medical Corporation | 2015-09-24 |
| 00650862220629 | ADVANTA SLIDER GDS | Atrium Medical Corporation | 2015-09-24 |
| 00650862220599 | ADVANTA SLIDER GDS | Atrium Medical Corporation | 2015-09-24 |
| 00650862220285 | ADVANTA SLIDER GDS | Atrium Medical Corporation | 2015-09-24 |
| 00650862220278 | ADVANTA SLIDER GDS | Atrium Medical Corporation | 2015-09-24 |
| 00650862220261 | ADVANTA SLIDER GDS | Atrium Medical Corporation | 2015-09-24 |
| 00650862220186 | ADVANTA SLIDER GDS | Atrium Medical Corporation | 2015-09-24 |
| 00650862220179 | ADVANTA SLIDER GDS | Atrium Medical Corporation | 2015-09-24 |
| 00650862220148 | ADVANTA SLIDER GDS | Atrium Medical Corporation | 2015-09-24 |