ReFlow Medical
FDA Regulatory Profile
ReFlow Medical appears in FDA public data with 1 recall — including 1 Class I (most serious) —, 20 510(k) clearances, 4 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1898-2017, Class I) was initiated on Mar 22, 2017. Its most recent 510(k) clearance was granted on Aug 28, 2026.
Summary
- Total Recalls
- 1 (1 Class I)
- 510(k) Clearances
- 20
- Inspections
- 4
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1898-2017 | Class I | Wingman 35 Crossing Catheter, 65cm, Model Numbers: WGM35065US WGM35065CE WGM35090US WGM3509 | Mar 22, 2017 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| 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 |
| K193012 | speX Support Catheter | Feb 19, 2020 |
| K190393 | Wingman 14C Crossing Catheter | May 9, 2019 |
| K173661 | Wingman 35 Crossing Catheter | Apr 18, 2018 |
| K173662 | speX Support Catheter | Dec 20, 2017 |
| K170996 | Wingman 14C Crossing Catheter | Jun 9, 2017 |
| K160848 | Wingman 18 Crossing Catheter | Jul 14, 2016 |
| K151880 | Wingman Crossing Catheter | Aug 7, 2015 |
| K141649 | SPEX SUPPORT CATHETER | Nov 5, 2014 |
| K141547 | WINGMAN EXTENDABLE TIP SUPPORT CATHETER | Sep 30, 2014 |
| K132420 | WINGMAN EXTENDABLE TIP SUPPORT CATHETER | Sep 19, 2013 |
| K120178 | WINGMAN EXTENDABLE TIP SUPPORT CATHETER | Feb 8, 2012 |
| K101479 | WINGMAN EXTENDABLE TIP SUPPORT CATHETER | Aug 11, 2010 |