Data / Medical devices / United States / Reflow Medical
Reflow Medical: FDA-registered device maker in Lake Forest, CA, United States, 13 510(k) clearances
Reflow Medical is registered with the FDA (registration 3027058844) in Lake Forest, CA, United States. It lists 3 device types. The FDA files 13 510(k) clearances under its listings, the newest dated August 28, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3027058844
- Address
- 20532 Crescent Bay Dr. Suite 100, Lake Forest, CA, United States, 92630
- Owner or operator
- Reflow Medical (10034685)
- Roles
- Contract manufacturer, Manufacturer, Repackager or relabeler
- First device listed
- December 16, 2014
- Registered through
- 2026
- Brand names listed
- Cora Microcatheters, Kiba CTO Crossing Catheter, SINC Support Catheter, Spex LP Support Catheters, Spex Support Catheters, Spur Peripheral Retrievable Stent System, Wingman 14 Crossing Catheter, Wingman 14C Crossing Catheter and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter For Crossing Total Occlusions | PDU | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Catheter, Percutaneous | DQY | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Peripheral Temporary And Retrievable Stent System | SEU | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 28, 2026 | K262013 | Kiba CTO Crossing Catheter | PDU | Substantially Equivalent | Reflow Medical, Inc. | accessdata.fda.gov |
| May 29, 2025 | DEN240048 | Spur Peripheral Retrievable Stent System | SEU | Unknown | Reflow Medical, Inc. | accessdata.fda.gov |
| February 8, 2024 | K233350 | SINC Support Catheter | DQY | Substantially Equivalent | Reflow Medical, Inc. | accessdata.fda.gov |
| May 28, 2021 | K210188 | coraCross | DQY | Substantially Equivalent | Reflow Medical | accessdata.fda.gov |
| October 26, 2020 | K201811 | coraForce and coraFlex Support Catheters | DQY | Substantially Equivalent | Reflow Medical, Inc. | accessdata.fda.gov |
| March 18, 2020 | K200094 | speX LP Support Catheter | DQY | Substantially Equivalent | Reflow Medical | accessdata.fda.gov |
| February 20, 2020 | K193596 | Wingman 14, Wingman 14C, Wingman 18, Wingman 35 | DQY | Substantially Equivalent | Reflow Medical | accessdata.fda.gov |
| February 19, 2020 | K193012 | speX Support Catheter | DQY | Substantially Equivalent | Reflow Medical | accessdata.fda.gov |
| May 9, 2019 | K190393 | Wingman 14C Crossing Catheter | DQY | Substantially Equivalent | Reflow Medical, Inc. | accessdata.fda.gov |
| April 18, 2018 | K173661 | Wingman 35 Crossing Catheter | DQY | Substantially Equivalent | Reflow Medical, Inc. | accessdata.fda.gov |
| December 20, 2017 | K173662 | speX Support Catheter | DQY | Substantially Equivalent | Reflow Medical, Inc. | accessdata.fda.gov |
| July 14, 2016 | K160848 | Wingman 18 Crossing Catheter | DQY | Substantially Equivalent | Reflow Medical, Inc. | accessdata.fda.gov |
| September 19, 2013 | K132420 | WINGMAN EXTENDABLE TIP SUPPORT CATHETER | DQY | Substantially Equivalent | Reflow Medical | accessdata.fda.gov |
Compare with other makers
- All makers of Catheter, Percutaneous
- All makers of Peripheral Temporary And Retrievable Stent System
- All makers of Catheter For Crossing Total Occlusions
Updated August 28, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.