Esperance
Model DAC6F115 · Shanghai Wallaby Medical Technologies Co., Inc. · DI 06970908211195
DQY — Catheter, Percutaneous · Class II · 21 CFR 870.1250
QJP — Catheter, Percutaneous, Neurovasculature · Class II · 21 CFR 870.1250
UDILibrary device dossier · generated 2026-09-06 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (0)
No recalls linked in the loaded window.
Adverse-event reports — MAUDE (0)
Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 2.64 |
| 2019-02 | 0 | 1.91 |
| 2019-03 | 0 | 1.81 |
| 2019-04 | 0 | 2.34 |
| 2019-05 | 0 | 1.76 |
| 2019-06 | 0 | 1.89 |
| 2019-07 | 0 | 2.49 |
| 2019-08 | 0 | 1.97 |
| 2019-09 | 0 | 1.58 |
| 2019-10 | 0 | 2.66 |
| 2019-11 | 0 | 1.92 |
| 2019-12 | 0 | 2.01 |
| 2020-01 | 0 | 2.82 |
| 2020-02 | 0 | 2.02 |
| 2020-03 | 0 | 2.19 |
| 2020-04 | 0 | 2.6 |
| 2020-05 | 0 | 2 |
| 2020-06 | 0 | 2.31 |
| 2020-07 | 0 | 3.13 |
| 2020-08 | 0 | 2.25 |
| 2020-09 | 0 | 2.22 |
| 2020-10 | 0 | 3.07 |
| 2020-11 | 0 | 2.29 |
| 2020-12 | 0 | 2.58 |
| 2021-01 | 0 | 2.52 |
| 2021-02 | 0 | 2.5 |
| 2021-03 | 0 | 2.38 |
| 2021-04 | 0 | 2.08 |
| 2021-05 | 0 | 2.7 |
| 2021-06 | 0 | 2.42 |
| 2021-07 | 0 | 2.04 |
| 2021-08 | 0 | 2.47 |
| 2021-09 | 0 | 2.07 |
| 2021-10 | 0 | 2.3 |
| 2021-11 | 0 | 1.94 |
| 2021-12 | 0 | 2.19 |
| 2022-01 | 0 | 2.17 |
| 2022-02 | 0 | 2.14 |
| 2022-03 | 0 | 1.87 |
| 2022-04 | 0 | 2.22 |
| 2022-05 | 0 | 1.85 |
| 2022-06 | 0 | 2.28 |
| 2022-07 | 0 | 2.04 |
| 2022-08 | 0 | 2.4 |
| 2022-09 | 0 | 2.11 |
| 2022-10 | 0 | 2.17 |
| 2022-11 | 0 | 2.12 |
| 2022-12 | 0 | 1.92 |
| 2023-01 | 0 | 1.82 |
| 2023-02 | 0 | 1.99 |
| 2023-03 | 0 | 1.99 |
| 2023-04 | 0 | 2.25 |
| 2023-05 | 0 | 1.93 |
| 2023-06 | 0 | 2.18 |
| 2023-07 | 0 | 2.14 |
| 2023-08 | 0 | 2.06 |
| 2023-09 | 0 | 1.99 |
| 2023-10 | 0 | 2.45 |
| 2023-11 | 0 | 2.51 |
| 2023-12 | 0 | 2.45 |
| 2024-01 | 0 | 1.96 |
| 2024-02 | 0 | 2.15 |
| 2024-03 | 0 | 1.91 |
| 2024-04 | 0 | 2.05 |
| 2024-05 | 0 | 1.97 |
| 2024-06 | 0 | 2.19 |
| 2024-07 | 0 | 2.06 |
| 2024-08 | 0 | 2.03 |
| 2024-09 | 0 | 2.28 |
| 2024-10 | 0 | 2.4 |
| 2024-11 | 0 | 2.63 |
| 2024-12 | 0 | 3.12 |
| 2025-01 | 0 | 3.09 |
| 2025-02 | 0 | 2.85 |
| 2025-03 | 0 | 2.78 |
| 2025-04 | 0 | 2.53 |
| 2025-05 | 0 | 2.69 |
| 2025-06 | 0 | 3.34 |
| 2025-07 | 0 | 3.45 |
| 2025-08 | 0 | 3.07 |
| 2025-09 | 0 | 3.02 |
| 2025-10 | 0 | 3.29 |
| 2025-11 | 0 | 3.47 |
| 2025-12 | 0 | 3.98 |
| 2026-01 | 0 | 3.9 |
| 2026-02 | 0 | 3.45 |
| 2026-03 | 0 | 3.4 |
| 2026-04 | 0 | 3.22 |
| 2026-05 | 0 | 3.52 |
| 2026-06 | 0 | 3.62 |
Regulatory clearances
- K231056 SESE 2024-03-08 (k number procode)
Predicate lineage
K231056 — cites (transitively): K182097 (d1), K211697 (d1), K110055 (d2), K151667 (d2), K180715 (d2), K090752 (d2), K142458 (d2), K180008 (d2), K070970 (d3), K072718 (d3), K100769 (d3), K113163 (d3), K133317 (d3), K090335 (d3), K110483 (d3), K114083 (d3), K133177 (d3), K122756 (d3), K162901 (d3), K080583 (d4), K153071 (d4), K160449 (d4), K161640 (d4), K113455 (d5), K123378 (d5), K141491 (d5), K051758 (d5), K151623 (d5), K152541 (d5), K063774 (d6), K081305 (d6), K082034 (d6), K090085 (d6)
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — Shanghai Wallaby Medical Technologies Co., Inc.
Nothing in the loaded window.