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Sign in to claim this brandREFLOW MEDICAL, INC.
United States·US-MF-000017521
Last updated September 17, 2026
What REFLOW MEDICAL, INC. makes
REFLOW MEDICAL, INC. manufactures vascular guide-catheters, single-use, and peripheral artery stents, bare-metal, including devices such as Spex LP, coraFlex, SPEX18, WINGMAN18, WINGMAN35, SPEX35, and WINGMAN18C.
The company's portfolio is regulated as Class II and Class IIa devices and is listed in eudamed, fda_510k, and fda_udi registries. REFLOW MEDICAL, INC. is based in the US.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What does REFLOW MEDICAL, INC. manufacture?
REFLOW MEDICAL, INC. manufactures vascular guide-catheters, single-use, and peripheral artery stents, bare-metal, including devices such as Spex LP, coraFlex, SPEX18, WINGMAN18, WINGMAN35, SPEX35, and WINGMAN18C.
Where is REFLOW MEDICAL, INC. based?
REFLOW MEDICAL, INC. is based in the US, as indicated in the provided device data.
Which regulatory registries list REFLOW MEDICAL, INC.'s devices?
REFLOW MEDICAL, INC.'s devices are listed in eudamed, fda_510k, and fda_udi registries, as specified in the device data.
How are REFLOW MEDICAL, INC.'s devices classified?
REFLOW MEDICAL, INC.'s devices are regulated as Class II and Class IIa devices, according to the provided device data.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- United States
- Address
- 208, Avenida Fabricante, San Clemente, United States
- Website
- reflowmedical.com
- —
- —
- [email protected]
- Phone
- 9494810399
- PRRC Contact
- Angela Lamprey
- EUDAMED SRN
- US-MF-000017521
- FDA FEI Number
- 3027058844
- DUNS Number
- 962545294
Catalogue (81)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| speX Support Catheter | K173662 | FDA 510(k) | Class II | Active |
| speX Support Catheter | K193012 | FDA 510(k) | Class II | Active |
| Wingman 35 Crossing Catheter | K173661 | FDA 510(k) | Class II | Active |
| Wingman 14C Crossing Catheter | K170996 | FDA 510(k) | Class II | Active |
| Wingman Extendable Tip Support Catheter | K141547 | FDA 510(k) | Class II | Active |
| Wingman 14C Crossing Catheter | K190393 | FDA 510(k) | Class II | Active |
| SINC Support Catheter | K233350 | FDA 510(k) | Class II | Active |
| Wingman Extendable Tip Support Catheter | K101479 | FDA 510(k) | Class II | Active |
| Wingman 18 Crossing Catheter | K160848 | FDA 510(k) | Class II | Active |
| CoraForce Microcatheter, CoraFlex Microcatheter | K251277 | FDA 510(k) | Class II | Active |
| Wingman Crossing Catheter | K151880 | FDA 510(k) | Class II | Active |
| Wingman Extendable Tip Support Catheter | K132420 | FDA 510(k) | Class II | Active |
| speX LP Support Catheter | K200094 | FDA 510(k) | Class II | Active |
| coraForce and coraFlex Support Catheters | K201811 | FDA 510(k) | Class II | Active |
| Spex Support Catheter | K141649 | FDA 510(k) | Class II | Active |
| Spex | SPX14090CE | EUDAMED | Class IIa | Active |
| Spur | BSPUR460150CE | EUDAMED | Class IIa | Active |
| Spur | BSPUR365135CE | EUDAMED | Class IIa | Active |
| Spex | SPN35090CE | EUDAMED | Class IIa | Active |
| Spex | SPN35135CE | EUDAMED | Class IIa | Active |
| Wingman | WMC14135CE | EUDAMED | Class IIa | Active |
| Spex LP | SLP14135CE | EUDAMED | Class IIa | Active |
| Wingman | WMC14150CE | EUDAMED | Class IIa | Active |
| Wingman | WGM35090CE | EUDAMED | Class IIa | Active |
| Spur | BSPUR460135CE | EUDAMEDFDA 510(k) | Class IIa | Active |
| Wingman | WGM14135CE | EUDAMED | Class IIa | Active |
| Wingman | WGM35135CE | EUDAMED | Class IIa | Active |
| Spex LP | SLP35150CE | EUDAMED | Class IIa | Active |
| Wingman | WGM14065CE | EUDAMED | Class IIa | Active |
| Wingman | WGM18150CE | EUDAMED | Class IIa | Active |
| Spex | SPX14135CE | EUDAMED | Class IIa | Active |
Related Companies
Authorised Representatives
Importers
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Notified Bodies
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Authorities
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FDA Recalls (1)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
ReFlow Medical, Inc. has one recall record initiated on 2017-03-22, which has been terminated. The recall was for the Wingman 35 Crossing Catheter due to a potential issue with tip detachment.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Mar 22, 2017 | Z-1898-2017 | — | terminated | ReFlow Medical is recalling the Wingman 35 Crossing Catheter because it may be prone to tip detachment. |
FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Reflow Medical, Inc San Clemente, CA · US FEI 3008789872