FDA.reportPublic FDA data

Reflow Medical

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30270588443027058844Reflow Medical1N2026-01-0120532 Crescent Bay Dr. Suite 100 Lake Forest CA US 92630

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3162171092162125K262013Kiba CTO Crossing CatheterPDU2026-08-28
3162171064735759K233350SINC Support CatheterDQY2024-02-08
3162172024355154K210188coraCrossDQY2021-05-28
3162171870626947K201811coraForce and coraFlex Support CathetersDQY2020-10-26
3162171954826965K200094speX LP Support CatheterDQY2020-03-18
3162171254767247K193596Wingman 14, Wingman 14C, Wingman 18, Wingman 35DQY2020-02-20
3162171795791649K193012speX Support CatheterDQY2020-02-19
3162171884602934K190393Wingman 14C Crossing CatheterDQY2019-05-09
3162171966664405K173662speX Support CatheterDQY2017-12-20
3162171524398028K173661Wingman 35 Crossing CatheterDQY2018-04-18
3162171038429017K160848Wingman 18 Crossing CatheterDQY2016-07-14
3162172036648913K132420WINGMAN EXTENDABLE TIP SUPPORT CATHETERDQY2013-09-19
3162171250573254DEN240048Spur Peripheral Retrievable Stent SystemSEU2025-05-29
3162171076420581

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DQY112024-02-08
PDU12026-08-28
SEU12025-05-29

PMN#