MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface; MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface with Bridge; MYOtherm XP Cardioplegia Delivery System; MYOtherm XP Cardioplegia Delivery System with Bridge
FDA 510(k) K162958 · Medtronic, Inc.
510(k) numberK162958
Submission
- Device name
- MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface; MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface with Bridge; MYOtherm XP Cardioplegia Delivery System; MYOtherm XP Cardioplegia Delivery System with Bridge
- Applicant
- Medtronic, Inc.
Minneapolis, MN, US - Received
- October 24, 2016
- Decision date
- February 1, 2017
- 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 |
| K201984 | MPS 3 ND Myocardial Protection SystemDTR · Traditional | Quest Medical, Inc. | 11/20/2020SE |
| 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 |
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| K261335 | VitalFlow Set with Balance BiosurfaceQJZ · Traditional | 07/31/2026SE |
| K261866 | Concerto Versa Detachable CoilKRD · Special | 06/24/2026SE |
| K253530 | Trexon Monofilament Synthetic Absorbable SutureGAM · Traditional | 05/28/2026SE |
| K260195 | Elongated One-Piece Arterial (EOPA) 3D Arterial CannulaeDWF · Special | 04/23/2026SE |
| K253203 | Retrograde Coronary Sinus Perfusion CannulaeDWF · Traditional | 02/19/2026SE |
| K253998 | Clearview Intracoronary ShuntsDWF · Special | 01/20/2026SE |
| K251744 | Affinity Pixie Arterial Filter with Balance Biosurface; Affinity® Pediatric Arterial…DTM · Special | 01/16/2026SE |
| K251831 | Bio-Medicus Life Support Catheter and IntroducerQHW · Traditional | 01/15/2026SE |
Questions and answers
When was MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface; MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface with Bridge; MYOtherm XP Cardioplegia Delivery System; MYOtherm XP Cardioplegia Delivery System with Bridge cleared by the FDA?
MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface; MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface with Bridge; MYOtherm XP Cardioplegia Delivery System; MYOtherm XP Cardioplegia Delivery System with Bridge (K162958) received a 510(k) decision of Substantially Equivalent on February 1, 2017, 100 days after the submission was received.
What is the product code of K162958?
The FDA product code is DTR – Heat-Exchanger, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4240.