MPS 3 ND Myocardial Protection System
FDA 510(k) K201984 · Quest Medical, Inc.
510(k) numberK201984
Submission
- Device name
- MPS 3 ND Myocardial Protection System
- Applicant
- Quest Medical, Inc.
Allen, TX, US - Received
- July 17, 2020
- Decision date
- November 20, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DTR – Heat-Exchanger, Cardiopulmonary Bypass
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4240
- Specialty
- Cardiovascular
- Life-sustaining
- Yes
Other 510(k)s with product code DTR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252541 | Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 WDTR · Traditional | Spectrum Medical S.R.L. | 03/12/2026SE |
| K240908 | Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module…DTR · Traditional | Spectrum Medical , Ltd. | 07/08/2025SE |
| K250150 | VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set); VANGUARD…DTR · Special | Sorin Group Italia S.R.L. | 05/30/2025SE |
| K240190 | MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP…DTR · Special | Medtronic | 02/23/2024SE |
| K223879 | Quantum PureFlow Standard Heat Exchangers (HX11W-S2, HX11W-S1M and HX11W-S2M)DTR · Special | Quara S.R.L. | 04/13/2023SE |
| K220110 | Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat ExchangerDTR · Traditional | Qura S.R.L | 05/06/2022SE |
| K212688 | Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat ExchangerDTR · Traditional | Qura S.R.L | 01/10/2022SE |
| K200438 | MPS 3 Myocardial Protection SystemDTR · Traditional | Quest Medical, Inc. | 06/19/2020SE |
| K173716 | MPS2 Myocardial Protection System ConsoleDTR · Traditional | Quest Medical, Inc. | 10/01/2018SE |
| K162774 | MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP…DTR · Traditional | Medtronic, Inc. | 02/10/2017SE |
More from Medtronic, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K241058 | Lyka® PORT Needle Free Access Device (4170Y)FPA · Traditional | 12/18/2024SE |
| K213846 | Q2 Blood Administration SetsFPA · Traditional | 06/05/2022SE |
| K213588 | Q2 IV Administration SetsFPA · Traditional | 06/02/2022SE |
| K202672 | Precision Delivery Infusion SetFPA · Traditional | 01/21/2021SE |
| K200438 | MPS 3 Myocardial Protection SystemDTR · Traditional | 06/19/2020SE |
| K182442 | MiniGuard Arterial Safety ValveMJJ · Traditional | 11/06/2018SE |
| K173716 | MPS2 Myocardial Protection System ConsoleDTR · Traditional | 10/01/2018SE |
| K162804 | Q2 Low Pressure Power Injection Extension SetFPA · Traditional | 03/08/2017SE |
| K162304 | Q2 Multiport IV Administration Sets and Extension Sets, Checkmate Multiport IV…FPA · Traditional | 12/06/2016SE |
| K151079 | Q2 Intravenous Adminstration Sets and Extension SetsFPA · Traditional | 09/30/2015SE |
Questions and answers
When was MPS 3 ND Myocardial Protection System cleared by the FDA?
MPS 3 ND Myocardial Protection System (K201984) received a 510(k) decision of Substantially Equivalent on November 20, 2020, 126 days after the submission was received.
What is the product code of K201984?
The FDA product code is DTR – Heat-Exchanger, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4240.