OCS Heart Leukocyte Depleting Filter
FDA 510(k) clearance K231362 · decided 2023-10-31
Clearance details
- K-number
- K231362
- Device name
- OCS Heart Leukocyte Depleting Filter
- Applicant
- TransMedics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2023-05-11
- Decision date
- 2023-10-31
- Days to decision
- 173 days
- Clearance type
- Traditional
- Product code
- DTM
- Device class
- 2
- Regulation number
- 870.4260
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Andover, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Organ Care System (OCS) Heart (P180051/S009) | TransMedics, Inc. | 2025-12-16 |
| Organ Care System (OCS) Liver (P200031/S012) | TransMedics, Inc. | 2025-12-16 |
| Organ Care System (OCS) Lung System (P160013/S020) | TransMedics, Inc. | 2025-12-16 |
| Organ Care System (OCS) Heart System (P180051/S008) | TransMedics, Inc. | 2025-10-22 |
| Organ Care System (OCS) Lung System (P160013/S019) | TransMedics, Inc. | 2025-10-22 |
| Organ Care System (OCS) Liver (P200031/S011) | TransMedics, Inc. | 2025-10-22 |
| Organ Care System (OCS) Liver (P200031/S010) | TransMedics, Inc. | 2025-07-01 |
| Organ Care System (OCS) Liver (P200031/S007) | TransMedics, Inc. | 2025-01-13 |