# Reflow Medical, Inc.

- Location (FDA's records): San Clemente, CA
- FDA decisions: 20 (2010–2026): 19 510(k) clearances and 1 De Novo grant
- Names in FDA's records: Reflow Medical, Inc. (10); Reflow Medical (10)
- Product codes: DQY (18), SEU (1), PDU (1)
- 510(k) review time since 2016: median 111 days, against 114 for FDA's reviews in the same codes and years (8 of 12 faster)
- Predicates its devices cite: 25 (16 its own); citations of its devices by later devices: 16 (16 its own)
- Recalls linked to its devices: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Vascular Solutions, Inc.: 3 (https://510kreport.com/company/vascular-solutions)
- Spectranetics Corp.: 3 (https://510kreport.com/company/spectranetics)
- Lumend, Inc.: 1 (https://510kreport.com/company/lumend)
- Bridgepoint Medical: 1 (https://510kreport.com/company/bridgepoint-medical)
- Volcano Corporation: 1 (https://510kreport.com/company/volcano)

## Its most-cited devices
- K132420: Wingman Extendable Tip Support Catheter (2013), cited by 2
- K141547: Wingman Extendable Tip Support Catheter (2014), cited by 2
- K173662: speX Support Catheter (2017), cited by 2
- K201811: coraForce and coraFlex Support Catheters (2020), cited by 1
- K190393: Wingman 14C Crossing Catheter (2019), cited by 1
- K200094: speX LP Support Catheter (2020), cited by 1

## Recent decisions
- K262013: Kiba CTO Crossing Catheter (Aug 28, 2026)
- K251277: CoraForce Microcatheter, CoraFlex Microcatheter (Aug 22, 2025)
- DEN240048: Spur Peripheral Retrievable Stent System (May 29, 2025)
- K233350: SINC Support Catheter (Feb 8, 2024)
- K210188: coraCross (May 28, 2021)
- K201811: coraForce and coraFlex Support Catheters (Oct 26, 2020)
- K200094: speX LP Support Catheter (Mar 18, 2020)
- K193596: Wingman 14, Wingman 14C, Wingman 18, Wingman 35 (Feb 20, 2020)

Source page: https://510kreport.com/company/reflow-medical