FDA.reportPublic FDA data

510(k) K261913

Device
X°Port Heart Preservation System
Applicant
Traferox Technologies, Inc.
510(k) number
K261913
Product code
MSB
Decision
Substantially Equivalent (SESE)
Decision date
2026-09-16
Date received
2026-06-08
Regulation
876.5880
Classification name
System And Accessories, Isolated Heart, Transport And Preservation
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Anuradha Iyer
Address
3505 Laird Rd. Unit 16 Mississauga CA L5L 5Y7 L5L 5Y7

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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