510(k) K262013

Device
Kiba CTO Crossing Catheter
Applicant
Reflow Medical, Inc.
510(k) number
K262013
Product code
PDU
Decision
Substantially Equivalent (SESE)
Decision date
2026-08-28
Date received
2026-06-15
Regulation
870.1250
Classification name
Catheter For Crossing Total Occlusions
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Angela Lamprey
Address
208 Avenida Fabricante Suite 100 San Clemente CA US 92688 92688

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PDU#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K252315Santreva™-ATK Endovascular Revasculariztion CatheterAngioSafe, Inc.2025-09-22
K251158PowerWire® 14 Radiofrequency Guidewire KitBaylis Medical Technologies, Inc.2025-09-11
K251376LimFlow ARCLimFlow, Inc.2025-05-31
K232562PowerWire Radiofrequency Guidewire KitBaylis Medical Technologies, Inc.2024-02-28
K230159SoundBite® Crossing System XS PeripheralSoundbite Medical Solutions, Inc.2023-08-28
K230594Tigereye ST CTO-Crossing CatheterAvinger, Inc.2023-04-25
K221163Tunnel Crossing CatheterTractus Vascular, LLC2023-01-19
K221541LimFlow ARCLimFlow, Inc.2022-08-31
K220544DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model 2.0)Ra Medical Systems,Inc2022-06-29
K211802GoBack Crossing CatheterUpstream Peripheral Technologies, Ltd.2022-03-01
K212468Tigereye CTO-Crossing CatheterAvinger, Inc.2022-01-06
K203363Crosser iQ CTO Recanalization SystemC.R. Bard, Inc.2021-08-12
K210664DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101)Ra Medical Systems,Inc2021-07-27
K210839SoundBite Crossing System - Peripheral (14P)Soundbite Medical Solutions, Inc.2021-04-20
K201330Tigereye CTO-Crossing CatheterAvinger, Inc.2020-09-10