Vascutek Cannula Graft, Model CGS2008S
FDA 510(k) K081560 · Vascutek, Ltd.
510(k) numberK081560
Submission
- Device name
- Vascutek Cannula Graft, Model CGS2008S
- Applicant
- Vascutek, Ltd.
Renfrewshire, Glasgow, GB - Received
- June 3, 2008
- Decision date
- February 10, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DWF – Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4210
- Specialty
- Cardiovascular
Other 510(k)s with product code DWF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260195 | Elongated One-Piece Arterial (EOPA) 3D Arterial CannulaeDWF · Special | Medtronic, Inc. | 04/23/2026SE |
| K250937 | Venous Return CannulaeDWF · Traditional | LivaNova USA, Inc. | 03/11/2026SE |
| K260043 | Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C)DWF · Traditional | Smart Reactors | 02/23/2026SE |
| K253203 | Retrograde Coronary Sinus Perfusion CannulaeDWF · Traditional | Medtronic, Inc. | 02/19/2026SE |
| K253671 | Dual Stage Venous CannulaeDWF · Traditional | Sorin Group Italia S.R.L. | 01/30/2026SE |
| K253998 | Clearview Intracoronary ShuntsDWF · Special | Medtronic, Inc. | 01/20/2026SE |
| K253106 | AngioVac CannulaDWF · Special | AngioDynamics, Inc. | 10/24/2025SE |
| K250283 | RAP Femoral Venous CannulaeDWF · Special | LivaNova USA, Inc. | 07/10/2025SE |
| K250610 | Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310)DWF · Special | Sorin Group Italia S.R.L. | 06/27/2025SE |
| K251258 | MC2 Two-Stage Venous Cannula; MC2X Three-Stage Venous CannulaDWF · Traditional | Medtronic, Inc. | 06/20/2025SE |
More from Medtronic, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K241550 | Gelweave Vascular ProsthesesDSY · Traditional | 02/27/2025SE |
| K241070 | Gelsoft Plus Vascular ProsthesesDSY · Traditional | 11/15/2024SE |
| K202703 | Vascutek Gelsoft Plus ERS Vascular GraftDSY · Traditional | 04/06/2021SE |
| K200955 | Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid PatchDXZ · Traditional | 07/08/2020SE |
| K162803 | Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular GraftsDSY · Traditional | 07/14/2017SE |
| K162794 | Gelweave Vascular GraftsDSY · Traditional | 06/30/2017SE |
| K093817 | Gelweave Branched Vascular Grafts with Radiopaque MarkersDSY · Special | 01/07/2010SE |
| K092863 | Maxiflo, TaperfloDSY · Special | 10/08/2009SE |
| K091778 | Vascutek Cobrahood Eptfe Vascular GraftsDSY · Traditional | 08/31/2009SE |
| K090987 | Vascutek Branched GelweaveDSY · Traditional | 06/19/2009SE |
Questions and answers
When was Vascutek Cannula Graft, Model CGS2008S cleared by the FDA?
Vascutek Cannula Graft, Model CGS2008S (K081560) received a 510(k) decision of Substantially Equivalent on February 10, 2009, 252 days after the submission was received.
What is the product code of K081560?
The FDA product code is DWF – Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4210.