Organ Care System (OCS) Heart System
FDA premarket approval P180051/S008 · decided 2025-10-22
Approval details
- PMA number
- P180051
- Supplement
- S008
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Organ Care System (OCS) Heart System
- Generic name
- Organ care system (OCS) heart system
- Applicant
- TransMedics, Inc.
- Date received
- 2025-09-29
- Decision date
- 2025-10-22
- Days to decision
- 23 days
- Decision code
- OK30
- Product code
- QIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Andover, MA
- Statement
- Changes in assembly inspection documentation
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| OCS Heart Leukocyte Depleting Filter (K231362) | TransMedics, Inc. | 2023-10-31 |
| OCS Lung Donor Flush Set (K222535) | TransMedics, Inc. | 2022-11-18 |
| OCS Lung Solution (K211314) | TransMedics, Inc. | 2021-07-29 |