ReFlow Medical

FDA Regulatory Profile

Summary

Total Recalls
1 (1 Class I)
510(k) Clearances
19
Inspections
3
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1898-2017Class IWingman 35 Crossing Catheter, 65cm, Model Numbers: WGM35065US WGM35065CE WGM35090US WGM3509March 22, 2017

Recent 510(k) Clearances

K-NumberDeviceDate
K251277CoraForce Microcatheter, CoraFlex MicrocatheterAugust 22, 2025
DEN240048Spur Peripheral Retrievable Stent SystemMay 29, 2025
K233350SINC Support CatheterFebruary 8, 2024
K210188coraCrossMay 28, 2021
K201811coraForce and coraFlex Support CathetersOctober 26, 2020
K200094speX LP Support CatheterMarch 18, 2020
K193596Wingman 14, Wingman 14C, Wingman 18, Wingman 35February 20, 2020
K193012speX Support CatheterFebruary 19, 2020
K190393Wingman 14C Crossing CatheterMay 9, 2019
K173661Wingman 35 Crossing CatheterApril 18, 2018
K173662speX Support CatheterDecember 20, 2017
K170996Wingman 14C Crossing CatheterJune 9, 2017
K160848Wingman 18 Crossing CatheterJuly 14, 2016
K151880Wingman Crossing CatheterAugust 7, 2015
K141649SPEX SUPPORT CATHETERNovember 5, 2014
K141547WINGMAN EXTENDABLE TIP SUPPORT CATHETERSeptember 30, 2014
K132420WINGMAN EXTENDABLE TIP SUPPORT CATHETERSeptember 19, 2013
K120178WINGMAN EXTENDABLE TIP SUPPORT CATHETERFebruary 8, 2012
K101479WINGMAN EXTENDABLE TIP SUPPORT CATHETERAugust 11, 2010