X°Port Heart Preservation System— 510(k) K261913
Substantially EquivalentTraferox Technologies, Inc.
FDA 510(k) clearance K261913 for X°Port Heart Preservation System, Substantially Equivalent on 2026-09-16. Applicant: Traferox Technologies, Inc.. Device class: 2.
Summary
Traferox Technologies, Inc. submitted the X°Port Heart Preservation System under product code MSB (System And Accessories, Isolated Heart, Transport And Preservation). The record doesn't describe the system beyond its name and code.
Class II, 21 CFR 876.5880. The Cardiovascular review panel handled it as a Traditional 510(k), though the record lists Gastroenterology, Urology as the classification panel. The decision was Substantially Equivalent.
Traferox filed from Mississauga, Canada. The decision came 100 calendar days after FDA received it (June 8 to September 16, 2026).
Clearance details
- Applicant
- Traferox Technologies, Inc.
- Product code
- Product code MSB
- Device class
- Class 2
- Regulation
- 21 CFR 876.5880
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mississauga, CA
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