510(k) K250723

Device
FreedomFlow™ Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere Configuration)
Applicant
Cardio Flow Inc.,
510(k) number
K250723
Product code
MCW
Decision
Substantially Equivalent (SESE)
Decision date
2025-04-25
Date received
2025-03-10
Regulation
870.4875
Classification name
Catheter, Peripheral, Atherectomy
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Michael Kallok
Address
3530 88th Ave. NE Blaine MN US 55014 55014

FDA Registration Numbers

Source Documents

510(k) summary PDF

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