510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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ReFlow Medical, Inc

San Clemente, CA, US

REFLOW MEDICAL, INC appears in FDA device records in San Clemente, CA. FDA records list 19 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
19
PMA records
0
Recall records
1
Registered establishments
2

510(k) clearance history

FDA records hold 19 510(k) clearances for ReFlow Medical, Inc between 2010 and 2025. The busiest year on record is 2020, with 4. The most recent is 2025, with 2.

Clearances by year, as a table
510(k) clearance decisions for ReFlow Medical, Inc, by decision year
YearClearances
20101
20121
20131
20142
20151
20161
20172
20181
20191
20204
20211
20241
20252
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K251277CoraForce Microcatheter, CoraFlex MicrocatheterDQYSubstantially Equivalent
DEN240048Spur Peripheral Retrievable Stent SystemSEUUnknown
K233350SINC Support CatheterDQYSubstantially Equivalent
K210188coraCrossDQYSubstantially Equivalent
K201811coraForce and coraFlex Support CathetersDQYSubstantially Equivalent
K200094speX LP Support CatheterDQYSubstantially Equivalent
K193596Wingman 14, Wingman 14C, Wingman 18, Wingman 35DQYSubstantially Equivalent
K193012speX Support CatheterDQYSubstantially Equivalent
K190393Wingman 14C Crossing CatheterDQYSubstantially Equivalent
K173661Wingman 35 Crossing CatheterDQYSubstantially Equivalent
K173662speX Support CatheterDQYSubstantially Equivalent
K170996Wingman 14C Crossing CatheterDQYSubstantially Equivalent
K160848Wingman 18 Crossing CatheterDQYSubstantially Equivalent
K151880Wingman Crossing CatheterDQYSubstantially Equivalent
K141649SPEX SUPPORT CATHETERDQYSubstantially Equivalent
K141547WINGMAN EXTENDABLE TIP SUPPORT CATHETERDQYSubstantially Equivalent
K132420WINGMAN EXTENDABLE TIP SUPPORT CATHETERDQYSubstantially Equivalent
K120178WINGMAN EXTENDABLE TIP SUPPORT CATHETERDQYSubstantially Equivalent
K101479WINGMAN EXTENDABLE TIP SUPPORT CATHETERDQYSubstantially Equivalent

Registered establishments

FDA registered establishments for ReFlow Medical, Inc, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30087898723008789872REFLOW MEDICAL, INC208 Avenida Fabricante, San Clemente, CA 92672 US2026
30270588443027058844Reflow Medical20532 Crescent Bay Dr. Suite 100, Lake Forest, CA 92630 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-1898-2017Wingman 35 Crossing Catheter, 65cm, Model Numbers: WGM35065US WGM35065CE WGM35090US WGM35090CE WGM35135US WGM35135CEReFlow Medical is recalling the Wingman 35 Crossing Catheter because it may be prone to tip detachment.Class ITerminated

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain