Medical Device Manufacturer · US , San Clemente , CA

Reflow Medical, Inc. - FDA 510(k) Cleared Devices

10 submissions · 9 cleared · Since 2016

Recent clearances: Kiba CTO Crossing Catheter, CoraForce Microcatheter, CoraFlex Microcatheter, SINC Support Catheter

10

Total

9

Cleared

1

Denied

FDA 510(k) Regulatory Record - Reflow Medical, Inc. Cardiovascular ✕

10 devices

1-10 of 10

Cleared Aug 28, 2026

Kiba CTO Crossing Catheter

Cardiovascular · 74d

Cleared Aug 22, 2025

CoraForce Microcatheter, CoraFlex Microcatheter

Cardiovascular · 120d

Not Cleared May 29, 2025

Spur Peripheral Retrievable Stent System

DEN240048 · SEU

Cardiovascular · 251d

Cleared Feb 08, 2024

SINC Support Catheter

Cardiovascular · 132d

Cleared Oct 26, 2020

coraForce and coraFlex Support Catheters

Cardiovascular · 117d

Cleared May 09, 2019

Wingman 14C Crossing Catheter

Cardiovascular · 79d

Cleared Apr 18, 2018

Wingman 35 Crossing Catheter

Cardiovascular · 140d

Cleared Dec 20, 2017

speX Support Catheter

Cardiovascular · 21d

Cleared Jun 09, 2017

Wingman 14C Crossing Catheter

Cardiovascular · 67d

Cleared Jul 14, 2016

Wingman 18 Crossing Catheter

Cardiovascular · 108d