Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Wallaby Medical with 8 510(k) clearances. The most recent is a 510(k) clearance dated Aug 18, 2026: p17 XR Microcatheter.
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 18, 2026 | p17 XR MicrocatheterK254071 · QJP | 510(k) clearances |
| Oct 1, 2024 | Esperance 3+ Aspiration Catheter SystemK240917 · NRY | 510(k) clearances |
| Mar 8, 2024 | Esperance Distal Access CatheterK231056 · QJP | 510(k) clearances |
| Oct 13, 2023 | Paragon 8F Balloon Guide CatheterK232437 · DQY | 510(k) clearances |
| Apr 25, 2023 | Wallaby 017 Micro CatheterK223139 · KRA | 510(k) clearances |
| Mar 2, 2023 | 6F Wallaby Long SheathK222603 · DQY | 510(k) clearances |
| Nov 16, 2021 | Esperance Aspiration Catheter SystemK211697 · NRY | 510(k) clearances |
| May 4, 2018 | Wallaby Avenir Coil SystemK173711 · HCG | 510(k) clearances |
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
