Tandemheart Femoral Venous Cannula Set
FDA 510(k) K133236 · Cardiacassist, Inc.
510(k) numberK133236
Submission
- Device name
- Tandemheart Femoral Venous Cannula Set
- Applicant
- Cardiacassist, Inc.
Pittsburgh, PA, US - Received
- October 21, 2013
- Decision date
- January 29, 2014
- 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 |
|---|---|---|
| K233736 | LifeSPARC SystemQNR · Traditional | 01/19/2024SE |
| K232480 | ProtekDuo Veno-Venous Cannula SetsPZS · Traditional | 10/06/2023SE |
| K232132 | LifeSPARC SystemKFM · Special | 08/03/2023SE |
| K211830 | LifeSPARC SystemQNR · Traditional | 11/15/2022SE |
| K202751 | TandemHeart Pump and Escort ControllerQNR · Traditional | 03/26/2021SE |
| K183623 | LifeSPARC Pump, LifeSPARC ControllerKFM · Traditional | 07/09/2019SE |
| K181150 | ProtekDuo Mini Veno-Venous Cannula SetDWF · Special | 05/25/2018SE |
| K162181 | Protek Duo Venous Dilator Set, Protek Solo Venous Dilator SetDRE · Traditional | 01/06/2017SE |
| K162214 | Protek Solo 24 Fr Venous Cannula SetDWF · Traditional | 11/30/2016SE |
| K160257 | PROTEK Duo 31 Fr. Veno-Venous Cannula SetDWF · Special | 03/04/2016SE |
Questions and answers
When was Tandemheart Femoral Venous Cannula Set cleared by the FDA?
Tandemheart Femoral Venous Cannula Set (K133236) received a 510(k) decision of Substantially Equivalent on January 29, 2014, 100 days after the submission was received.
What is the product code of K133236?
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.