Data / Medical devices / United States / Reflow Medical, Inc
Reflow Medical, Inc: FDA-registered device maker in San Clemente, CA, United States, 13 510(k) clearances
Reflow Medical, Inc is registered with the FDA (registration 3008789872) in San Clemente, CA, United States. It lists 3 device types. The FDA files 13 510(k) clearances under its listings, the newest dated August 28, 2026. 1 recall event names it as the recalling firm (1 Class I). Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3008789872
- Address
- 208 Avenida Fabricante Suite 100, San Clemente, CA, United States, 92672
- Owner or operator
- Reflow Medical (10034685)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- December 16, 2014
- Registered through
- 2026
- Brand names listed
- Cora Microcatheters, Kiba CTO Crossing Catheter, Spex LP Support Catheters, Spex Support Catheters, Spur Peripheral Retrievable Stent System, Wingman 14 Crossing Catheter, Wingman 14C Crossing Catheter, Wingman 35 Crossing Catheter and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter For Crossing Total Occlusions | PDU | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Catheter, Percutaneous | DQY | 2 | Manufacturer | accessdata.fda.gov |
| Peripheral Temporary And Retrievable Stent System | SEU | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 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 |
| August 22, 2025 | K251277 | CoraForce Microcatheter, CoraFlex Microcatheter | DQY | 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 |
| 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 |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| March 22, 2017 | 76821 | Class I | Terminated | Wingman 35 Crossing Catheter, 65cm, Model Numbers: WGM35065US WGM35065CE WGM35090US WGM35090CE WGM35135US WGM35135CE | ReFlow Medical is recalling the Wingman 35 Crossing Catheter because it may be prone to tip detachment. | accessdata.fda.gov |
Compare with other makers
- All makers of Catheter For Crossing Total Occlusions
- All makers of Peripheral Temporary And Retrievable Stent System
- All makers of Catheter, Percutaneous
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.