510(k) clearance
X°Port Heart Preservation System
- 510(k) number
- K261913
- Applicant
- Traferox Technologies, Inc.
- Decision date
- Sep 16, 2026
- Date received
- Jun 8, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- MSB
- Device type
- System And Accessories, Isolated Heart, Transport And Preservation
- Device class
- Class II
- Regulation
- 21 CFR 876.5880
- Advisory committee
- Gastroenterology, Urology
- Statement or summary
- Summary
- Third party
- N
- Location
- Mississauga, CA