3T Vessel Cannulas
FDA 510(k) K020768 · 3t Medical Systems, LLC
510(k) numberK020768
Submission
- Device name
- 3T Vessel Cannulas
- Applicant
- 3t Medical Systems, LLC
Conifer, CO, US - Received
- March 7, 2002
- Decision date
- August 23, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|
| K072697 | 3T Blood Collection Cardiotomy Reservoirs and AccessoriesDTN · Traditional | 12/20/2007SE |
| K022287 | 3T/SEWOON Temperature Sensing Foley CathetersEZL · Traditional | 09/23/2002SE |
| K020365 | 3TM Myocardial Needle-Temperature ProbeKRI · Traditional | 05/03/2002SE |
| K001245 | 3T L. V. Control ValveMJJ · Traditional | 08/15/2001SE |
Questions and answers
When was 3T Vessel Cannulas cleared by the FDA?
3T Vessel Cannulas (K020768) received a 510(k) decision of Substantially Equivalent on August 23, 2002, 169 days after the submission was received.
What is the product code of K020768?
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.