Reflow Medical, Inc. is one of 17568 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Reflow Medical, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Kiba CTO Crossing Catheter, CoraForce Microcatheter, CoraFlex Microcatheter, SINC Support Catheter
10
Total
9
Cleared
1
Denied
Reflow Medical, Inc. has 9 FDA 510(k) cleared cardiovascular devices. Based in San Clemente, US.
Latest FDA clearance: Aug 2026. Active since 2016.
Browse the complete list of FDA 510(k) cleared cardiovascular devices from this manufacturer. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Reflow Medical, Inc.
10 devices
Cleared
Aug 28, 2026
Kiba CTO Crossing Catheter
Cardiovascular
74d
Cleared
Aug 22, 2025
CoraForce Microcatheter, CoraFlex Microcatheter
Cardiovascular
120d
Not Cleared
May 29, 2025
Spur Peripheral Retrievable Stent System
Cardiovascular
251d
Cleared
Feb 08, 2024
SINC Support Catheter
Cardiovascular
132d
Cleared
Oct 26, 2020
coraForce and coraFlex Support Catheters
Cardiovascular
117d
Cleared
May 09, 2019
Wingman 14C Crossing Catheter
Cardiovascular
79d
Cleared
Apr 18, 2018
Wingman 35 Crossing Catheter
Cardiovascular
140d
Cleared
Dec 20, 2017
speX Support Catheter
Cardiovascular
21d
Cleared
Jun 09, 2017
Wingman 14C Crossing Catheter
Cardiovascular
67d
Cleared
Jul 14, 2016
Wingman 18 Crossing Catheter
Cardiovascular
108d