VitaSmart Hypothermic Oxygenated Perfusion System
FDA 510(k) clearance DEN250009 · decided 2026-01-15
Clearance details
- K-number
- DEN250009
- Device name
- VitaSmart Hypothermic Oxygenated Perfusion System
- Applicant
- Bridge TO Life, Ltd.
- Decision
- Unknown
- Date received
- 2025-03-31
- Decision date
- 2026-01-15
- Days to decision
- 290 days
- Clearance type
- Direct
- Product code
- SGY
- Device class
- 2
- Regulation number
- 876.5881
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Northbrook, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.