Total clearances
9
2020-02-19 → 2026-08-28
Name variants in FDA filings: Reflow Medical, Inc. / Reflow Medical
Trend
Clearance cadence by quarter
Portfolio
Product codes worked
| Code |
Device name |
Class |
Specialty |
Clearances |
Most recent |
| DQY |
Catheter, Percutaneous |
Class II |
Cardiovascular |
7 |
2025-08-22 |
| PDU |
Catheter For Crossing Total Occlusions |
Class II |
Cardiovascular |
1 |
2026-08-28 |
| SEU |
Peripheral Temporary And Retrievable Stent System |
Class II |
Cardiovascular |
1 |
2025-05-29 |
Filings
All 510(k) clearances (9)
| Date |
K-number |
Device |
Code |
Class |
Specialty |
| 2026-08-28 |
K262013 |
Kiba CTO Crossing Catheter |
PDU |
Class II |
Cardiovascular |
| 2025-08-22 |
K251277 |
CoraForce Microcatheter, CoraFlex Microcatheter |
DQY |
Class II |
Cardiovascular |
| 2025-05-29 |
DEN240048 |
Spur Peripheral Retrievable Stent System |
SEU |
Class II |
Cardiovascular |
| 2024-02-08 |
K233350 |
SINC Support Catheter |
DQY |
Class II |
Cardiovascular |
| 2021-05-28 |
K210188 |
coraCross |
DQY |
Class II |
Cardiovascular |
| 2020-10-26 |
K201811 |
coraForce and coraFlex Support Catheters |
DQY |
Class II |
Cardiovascular |
| 2020-03-18 |
K200094 |
speX LP Support Catheter |
DQY |
Class II |
Cardiovascular |
| 2020-02-20 |
K193596 |
Wingman 14, Wingman 14C, Wingman 18, Wingman 35 |
DQY |
Class II |
Cardiovascular |
| 2020-02-19 |
K193012 |
speX Support Catheter |
DQY |
Class II |
Cardiovascular |