Product code MAL
- Device name
- Graft, Vascular, Synthetic/Biologic Composite
- 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 |
|---|---|---|---|
| P890045S001 | VASCUTEK GELSOFT(TM) VASCULAR GRAFT | Carbomedics, Inc. | 1995-07-05 |
| P890045S005 | VASCUTEK GELSEAL(TM) VASCULAR GRAFT | Carbomedics, Inc. | 1995-04-13 |
| P920027 | ALBUMIN COATED DEBAKEY(R) VASCULAR(R) VASCULAR-II | C.R. Bard, Inc. | 1994-10-21 |
| P890045S006 | VASCUTEK GELSEAL(TM) VASCULAR GRAFT | Carbomedics, Inc. | 1994-07-22 |
| P890045S003 | VASCUTEK GELSOFT(TM) VASCULAR GRAFT | Carbomedics, Inc. | 1993-12-07 |
| P890045 | GELSEAL TM TRIAXIAL VASCULAR GRAFT | Carbomedics, Inc. | 1993-01-11 |
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K122612 | HEMASHIELD WOVEN DOUBLE VELOUR VASCULAR GRAFT MODEL M00202175XXXXX; M00202166XXXXX | Maquet Cardiovascular, LLC | 2012-09-10 |
| K103080 | ALBOGRAFT VASCULAR PROSTHESIS | LeMaitre Vascular, Inc. | 2011-01-19 |
| K093231 | ALBOGRAFT VASCULAR PROSTHESIS | LeMaitre Vascular, Inc. | 2010-01-14 |
| K052302 | HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR TAAA GRAFT CONFIGURATION | Boston Scientific Corp | 2005-09-12 |
| K021213 | MODIFICATION TO HEMASHIELD PLATINUM WOVEN/MICROVEL DOUBLE VELOUR VASCULAR GRAFTS | Boston Scientific Corp | 2002-04-19 |
| K954848 | HEMASHIELD MICROVEL VELOUR KNITTED VASCULAR GRAFT | Meadox Medicals, Div. Boston Scientific Corp. | 1996-02-01 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00840663110353 | AlboGraft Polyester Vascular Graft | Lemaitre Vascular, Inc. | 2021-06-18 |
| 00840663110360 | AlboGraft Polyester Vascular Graft | Lemaitre Vascular, Inc. | 2021-06-18 |
| 00840663110377 | AlboGraft Polyester Vascular Graft | Lemaitre Vascular, Inc. | 2021-06-18 |
| 00840663110384 | AlboGraft Polyester Vascular Graft | Lemaitre Vascular, Inc. | 2021-06-18 |
| 00840663110391 | AlboGraft Polyester Vascular Graft | Lemaitre Vascular, Inc. | 2021-06-18 |
| 00840663110407 | AlboGraft Polyester Vascular Graft | Lemaitre Vascular, Inc. | 2021-06-18 |
| 00840663110414 | AlboGraft Polyester Vascular Graft | Lemaitre Vascular, Inc. | 2021-06-18 |
| 00840663110421 | AlboGraft Polyester Vascular Graft | Lemaitre Vascular, Inc. | 2021-06-18 |
| 00840663110438 | AlboGraft Polyester Vascular Graft | Lemaitre Vascular, Inc. | 2021-06-18 |
| 00840663110445 | AlboGraft Polyester Vascular Graft | Lemaitre Vascular, Inc. | 2021-06-18 |
| 05037881999463 | Gelsoft™ | VASCUTEK LTD | 2015-10-19 |
| 05037881999456 | Gelsoft™ | VASCUTEK LTD | 2015-10-19 |
| 05037881002903 | SealPTFE™ | VASCUTEK LTD | 2015-10-19 |
| 00840663102976 | AlboGraft Polyester Vascular Graft | Lemaitre Vascular, Inc. | 2015-10-16 |
| 00840663102969 | AlboGraft Polyester Vascular Graft | Lemaitre Vascular, Inc. | 2015-10-16 |
| 00840663102952 | AlboGraft Polyester Vascular Graft | Lemaitre Vascular, Inc. | 2015-10-16 |
| 00840663102945 | AlboGraft Polyester Vascular Graft | Lemaitre Vascular, Inc. | 2015-10-16 |
| 00840663102938 | AlboGraft Polyester Vascular Graft | Lemaitre Vascular, Inc. | 2015-10-16 |
| 00840663102921 | AlboGraft Polyester Vascular Graft | Lemaitre Vascular, Inc. | 2015-10-16 |
| 00840663102914 | AlboGraft Polyester Vascular Graft | Lemaitre Vascular, Inc. | 2015-10-16 |
| 00840663102907 | AlboGraft Polyester Vascular Graft | Lemaitre Vascular, Inc. | 2015-10-16 |
| 00840663102891 | AlboGraft Polyester Vascular Graft | Lemaitre Vascular, Inc. | 2015-10-16 |
| 00840663102884 | AlboGraft Polyester Vascular Graft | Lemaitre Vascular, Inc. | 2015-10-16 |
| 00840663102877 | AlboGraft Polyester Vascular Graft | Lemaitre Vascular, Inc. | 2015-10-16 |
| 00840663102860 | AlboGraft Polyester Vascular Graft | Lemaitre Vascular, Inc. | 2015-10-16 |
| 00840663102853 | AlboGraft Polyester Vascular Graft | Lemaitre Vascular, Inc. | 2015-10-16 |
| 00840663102846 | AlboGraft Polyester Vascular Graft | Lemaitre Vascular, Inc. | 2015-10-16 |
| 00840663102839 | AlboGraft Polyester Vascular Graft | Lemaitre Vascular, Inc. | 2015-10-16 |
| 00840663102822 | AlboGraft Polyester Vascular Graft | Lemaitre Vascular, Inc. | 2015-07-30 |
| 00840663102815 | AlboGraft Polyester Vascular Graft | Lemaitre Vascular, Inc. | 2015-07-30 |