TandemLung Oxygenator
FDA 510(k) K153295 · Cardiacassist, Inc.
510(k) numberK153295
Submission
- Device name
- TandemLung Oxygenator
- Applicant
- Cardiacassist, Inc.
Pittsburgh, PA, US - Received
- November 13, 2015
- Decision date
- February 26, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DTZ – Oxygenator, Cardiopulmonary Bypass
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4350
- Specialty
- Cardiovascular
- Life-sustaining
- Yes
Other 510(k)s with product code DTZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253838 | Lifemotion Disposable Membrane OxygenatorDTZ · Traditional | Lifemotion Medical Technology Co., Ltd. | 03/16/2026SE |
| K240934 | Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum Perfusion Blood…DTZ · Traditional | Spectrum Medical S.R.L. | 03/12/2026SE |
| K250821 | Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and Horizon CVR)…DTZ · Traditional | Eurosets S.R.L | 12/12/2025SE |
| K242503 | Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232)DTZ · Traditional | Eurosets S.R.L | 11/24/2025SE |
| K231982 | Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2DTZ · Traditional | Qura S.R.L | 09/12/2024SE |
| K240666 | Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface…DTZ · Traditional | Medtronic Perfusion Systems | 07/10/2024SE |
| K241352 | Affinity NT Oxygenator and Uncoated Cardiotomy/ Venous Reservoir (541); Affinity NT…DTZ · Special | Medtronic, Inc. | 06/12/2024SE |
| K231652 | D100 Kids; D101 KidsDTZ · Special | Sorin Group Italia S.R.L. | 11/16/2023SE |
| K231773 | Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT75-C1U, Quantum…DTZ · Traditional | Qura S.R.L | 11/08/2023SE |
| K231414 | CMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009)DTZ · Traditional | Chalice Medical , Ltd. | 11/01/2023SE |
More from Chalice Medical , Ltd.
| 510(k) | Device | Decision |
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| 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 TandemLung Oxygenator cleared by the FDA?
TandemLung Oxygenator (K153295) received a 510(k) decision of Substantially Equivalent on February 26, 2016, 105 days after the submission was received.
What is the product code of K153295?
The FDA product code is DTZ – Oxygenator, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4350.