FDA.reportPublic FDA data

REFLOW MEDICAL, INC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30087898723008789872REFLOW MEDICAL, INC1N2026-01-01208 Avenida Fabricante Suite 100 San Clemente CA US 92672

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1242851092162125K262013Kiba CTO Crossing CatheterPDU2026-08-28
1242851076420581K251277CoraForce Microcatheter, CoraFlex MicrocatheterDQY2025-08-22
1242852024355154K210188coraCrossDQY2021-05-28
1242851870626947K201811coraForce and coraFlex Support CathetersDQY2020-10-26
1242851954826965K200094speX LP Support CatheterDQY2020-03-18
1242851254767247K193596Wingman 14, Wingman 14C, Wingman 18, Wingman 35DQY2020-02-20
1242851795791649K193012speX Support CatheterDQY2020-02-19
1242851884602934K190393Wingman 14C Crossing CatheterDQY2019-05-09
1242851966664405K173662speX Support CatheterDQY2017-12-20
1242851524398028K173661Wingman 35 Crossing CatheterDQY2018-04-18
1242851038429017K160848Wingman 18 Crossing CatheterDQY2016-07-14
1242852036648913K132420WINGMAN EXTENDABLE TIP SUPPORT CATHETERDQY2013-09-19
1242851250573254DEN240048Spur Peripheral Retrievable Stent SystemSEU2025-05-29

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DQY112025-08-22
PDU12026-08-28
SEU12025-05-29