Venaflo PTFE Vascular Graft, Venaflo Graft with Carbon, Venaflo Vascular Graft
FDA 510(k) K981079 · Impra, Inc.
510(k) numberK981079
Submission
- Device name
- Venaflo PTFE Vascular Graft, Venaflo Graft with Carbon, Venaflo Vascular Graft
- Applicant
- Impra, Inc.
Tempe, AZ, US - Received
- March 24, 1998
- Decision date
- May 7, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DSY – Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.3450
- Specialty
- Cardiovascular
- Implant
- Yes
Other 510(k)s with product code DSY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252445 | Fusion Bioline Vascular GraftDSY · Traditional | Maquet Cardiovascular, LLC | 04/27/2026SE |
| K252277 | Spiral Laminar Flow Vascular Arteriovenous Graft (AV0645)DSY · Traditional | Vascular Flow Technologies Limited | 10/20/2025SE |
| K241550 | Gelweave Vascular ProsthesesDSY · Traditional | Vascutek, Ltd. | 02/27/2025SE |
| K241070 | Gelsoft Plus Vascular ProsthesesDSY · Traditional | Vascutek, Ltd. | 11/15/2024SE |
| K231972 | Advanta VXT Vascular Graft, Flixene Vascular GraftDSY · Traditional | Atrium Medical Corporation | 03/28/2024SE |
| K240083 | GORE® PROPATEN® Vascular GraftDSY · Traditional | W. L. Gore & Associates, Inc. | 03/01/2024SE |
| K233783 | exGraft ePTFE Vascular Grafts, exGraft Carbon ePTFE Vascular GraftsDSY · Traditional | Peca Labs, Inc. | 01/17/2024SE |
| K232312 | GORE® PROPATEN® Vascular GraftDSY · Traditional | W. L. Gore & Associates, Inc. | 01/09/2024SE |
| K233551 | GORE® ACUSEAL Vascular GraftDSY · Traditional | W. L. Gore & Associates, Inc. | 12/19/2023SE |
| K231505 | GORE® ACUSEAL Vascular GraftDSY · Special | W. L. Gore & Associates, Inc. | 06/23/2023SE |
More from W. L. Gore & Associates, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K004012 | Impra Carboflo Eptfe Vascular GraftsDYF · Traditional | 05/14/2001SE |
| K004011 | Impra Carboflo Vascular Graft, Impra Carboflo Vascular Grafts for A-V AccessDSY · Traditional | 03/27/2001SE |
| K991027 | Bi-Directional TunnelerDSY · Special | 04/22/1999SE |
| K983769 | Distaflo Bypass GraftDYF · Abbreviated | 12/15/1998SE |
| K983861 | Distaflo Bypass GraftDSY · Abbreviated | 11/24/1998SE |
| K983064 | Impra High Porosity GraftDSY · Traditional | 11/19/1998SE |
| K981076 | Venaflo PTFE Vascular Graft, Venaflo Graft with Carbon, Venaflo Vascular GraftDYF · Traditional | 05/07/1998SE |
| K971192 | Impra Eptfe Arteriovenous Cuffed GraftDSY · Traditional | 04/15/1997ST |
| K964877 | Impra Eptfe Arteriovenous Cuffed GraftDYF · Traditional | 03/20/1997ST |
| K964197 | Impra Carboflo Eptfe Vascular GraftDSY · Traditional | 01/02/1997SE |
Questions and answers
When was Venaflo PTFE Vascular Graft, Venaflo Graft with Carbon, Venaflo Vascular Graft cleared by the FDA?
Venaflo PTFE Vascular Graft, Venaflo Graft with Carbon, Venaflo Vascular Graft (K981079) received a 510(k) decision of Substantially Equivalent on May 7, 1998, 44 days after the submission was received.
What is the product code of K981079?
The FDA product code is DSY – Prosthesis, Vascular Graft, Of 6mm And Greater Diameter, a Class II (moderate risk) device regulated under 21 CFR 870.3450.