DTM
- Product code
- DTM
- Device name
- Filter, Blood, Cardiopulmonary Bypass, Arterial Line
- Device class
- Class 2
- 21 CFR
- 21 CFR 870.4260
- 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)
- 96 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (4)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K251744 | 2026-01-16 | Medtronic | Affinity Pixie Arterial Filter with Balance Biosur | |
| K242953 | 2024-12-20 | Sorin Group Italia S.R.L. | KIDS Arterial Filters | |
| K242092 | 2024-11-18 | Sorin Group Italia S.R.L. | MICRO Arterial Filters | |
| K231362 | 2023-10-31 | TransMedics, Inc. | OCS Heart Leukocyte Depleting Filter |
Official FDA classification page: DTM
Classification and pathway per current FDA publications. Data from openFDA (CC0).