FDA.reportPublic FDA data

REFLOW MEDICAL, INC

Matched from indexed company URL: Reflow Medical

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30087898723008789872REFLOW MEDICAL, INC1N2026-01-01208 Avenida Fabricante Suite 100 San Clemente CA US 92672
30270588443027058844Reflow Medical1N2026-01-0120532 Crescent Bay Dr. Suite 100 Lake Forest CA US 92630

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00856492005197WINGMAN14 - Wingman Crossing Catheter, 14X65cm949.481.0399quality@reflowmedical.com
00856492005234WINGMAN18 - Wingman Crossing Catheter, 18X90cm949.481.0399quality@reflowmedical.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1242851076420581K251277CoraForce Microcatheter, CoraFlex MicrocatheterDQY2025-08-22
3162171064735759K233350SINC Support CatheterDQY2024-02-08
1242852024355154K210188coraCrossDQY2021-05-28
3162172024355154K210188coraCrossDQY2021-05-28
1242851870626947K201811coraForce and coraFlex Support CathetersDQY2020-10-26
3162171870626947K201811coraForce and coraFlex Support CathetersDQY2020-10-26
1242851954826965K200094speX LP Support CatheterDQY2020-03-18
3162171954826965K200094speX LP Support CatheterDQY2020-03-18
1242851254767247K193596Wingman 14, Wingman 14C, Wingman 18, Wingman 35DQY2020-02-20
3162171254767247K193596Wingman 14, Wingman 14C, Wingman 18, Wingman 35DQY2020-02-20
1242851795791649K193012speX Support CatheterDQY2020-02-19
3162171795791649K193012speX Support CatheterDQY2020-02-19
3162171884602934K190393Wingman 14C Crossing CatheterDQY2019-05-09
1242851884602934K190393Wingman 14C Crossing CatheterDQY2019-05-09
3162171966664405K173662speX Support CatheterDQY2017-12-20
1242851966664405K173662speX Support CatheterDQY2017-12-20
1242851524398028K173661Wingman 35 Crossing CatheterDQY2018-04-18
3162171524398028K173661Wingman 35 Crossing CatheterDQY2018-04-18
1242851038429017K160848Wingman 18 Crossing CatheterDQY2016-07-14
3162171038429017K160848Wingman 18 Crossing CatheterDQY2016-07-14
3162172036648913K132420WINGMAN EXTENDABLE TIP SUPPORT CATHETERDQY2013-09-19
1242852036648913K132420WINGMAN EXTENDABLE TIP SUPPORT CATHETERDQY2013-09-19
1242851250573254DEN240048Spur Peripheral Retrievable Stent SystemSEU2025-05-29
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
DQY222025-08-22
SEU22025-05-29

PMN#

GUDID#

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