Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C)
FDA 510(k) K260043 · Smart Reactors
510(k) numberK260043
Submission
- Device name
- Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C)
- Applicant
- Smart Reactors
Galway, IE - Received
- January 7, 2026
- Decision date
- February 23, 2026
- 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 |
| 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 |
| K241248 | Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1)DWF · Special | Spectrum Medical S.R.L. | 05/31/2024SE |
Questions and answers
When was Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C) cleared by the FDA?
Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C) (K260043) received a 510(k) decision of Substantially Equivalent on February 23, 2026, 47 days after the submission was received.
What is the product code of K260043?
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.