Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1)
FDA 510(k) K241248 · Spectrum Medical S.R.L.
510(k) numberK241248
Submission
- Device name
- Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1)
- Applicant
- Spectrum Medical S.R.L.
Mirandola, IT - Received
- May 3, 2024
- Decision date
- May 31, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|
| K252541 | Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 WDTR · Traditional | 03/12/2026SE |
| K240934 | Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum Perfusion Blood…DTZ · Traditional | 03/12/2026SE |
| K251762 | Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG)KFM · Traditional | 08/04/2025SE |
| K250326 | Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG)KFM · Traditional | 06/24/2025SE |
| K241206 | Quantum Perfusion Hybrid SystemDTN · Traditional | 07/18/2024SE |
Questions and answers
When was Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1) cleared by the FDA?
Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1) (K241248) received a 510(k) decision of Substantially Equivalent on May 31, 2024, 28 days after the submission was received.
What is the product code of K241248?
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.