DTR
- Product code
- DTR
- Device name
- Heat-Exchanger, Cardiopulmonary Bypass
- Device class
- Class 2
- 21 CFR
- 21 CFR 870.4240
- Medical specialty
- Cardiovascular
- Marketing pathway
- 510(K)
- Flag
- Life-sustaining / life-supporting
- 510(k) clearances (last 3 years)
- 4
- Summaries archived here
- 4 (direct download)
- 510(k) clearances (all years, FDA)
- 91 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (4)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K252541 | 2026-03-12 | Spectrum Medical S.R.L. | Quantum PureFlow Standard Heat Exchanger Medium Flow… | |
| K240908 | 2025-07-08 | Spectrum Medical , Ltd. | Quantum Micro-Cardioplegia Delivery System; Quantum … | |
| K250150 | 2025-05-30 | Sorin Group Italia S.R.L. | VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Bl… | |
| K240190 | 2024-02-23 | Medtronic | MYOtherm XP Cardioplegia Delivery System with Cortiv… |
Official FDA classification page: DTR
Classification and pathway per current FDA publications. Data from openFDA (CC0).