Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list ReFlow Medical with 19 510(k) clearances and 1 device recall. The most recent is a 510(k) clearance dated Aug 28, 2026: Kiba CTO Crossing Catheter.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Aug 28, 2026 | Kiba CTO Crossing CatheterK262013 · PDU | 510(k) clearances |
| Aug 22, 2025 | CoraForce Microcatheter, CoraFlex MicrocatheterK251277 · DQY | 510(k) clearances |
| May 29, 2025 | Spur Peripheral Retrievable Stent SystemDEN240048 · SEU | 510(k) clearances |
| Feb 8, 2024 | SINC Support CatheterK233350 · DQY | 510(k) clearances |
| May 28, 2021 | coraCrossK210188 · DQY | 510(k) clearances |
| Oct 26, 2020 | coraForce and coraFlex Support CathetersK201811 · DQY | 510(k) clearances |
| Mar 18, 2020 | speX LP Support CatheterK200094 · DQY | 510(k) clearances |
| Feb 20, 2020 | Wingman 14, Wingman 14C, Wingman 18, Wingman 35K193596 · DQY | 510(k) clearances |
| Mar 22, 2017 | Wingman 35 Crossing Catheter, 65cm, Model Numbers: WGM35065US WGM35065CE WGM35090US WGM35090CE WGM35135US WGM35135CEClass I · ReFlow Medical is recalling the Wingman 35 Crossing Catheter because it may be prone to tip detachment. | Device recalls |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
