APRO 45 Swift Catheter
Model FG-02273-160-AC · Alembic, LLC · DI 00850014025212
NRY — Catheter, Thrombus Retriever · Class II · 21 CFR 870.1250
UDILibrary device dossier · generated 2026-09-07 · 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 | 3.27 |
| 2019-03 | 0 | 2.21 |
| 2019-04 | 0 | 2.4 |
| 2019-05 | 0 | 2.18 |
| 2019-06 | 0 | 3.28 |
| 2019-07 | 0 | 3.95 |
| 2019-08 | 0 | 3.9 |
| 2019-09 | 0 | 2.53 |
| 2019-10 | 0 | 3.61 |
| 2019-11 | 0 | 3.11 |
| 2019-12 | 0 | 3.55 |
| 2020-01 | 0 | 3.91 |
| 2020-02 | 0 | 5.88 |
| 2020-03 | 0 | 3.63 |
| 2020-04 | 0 | 3.42 |
| 2020-05 | 0 | 4.13 |
| 2020-06 | 0 | 3.5 |
| 2020-07 | 0 | 3.28 |
| 2020-08 | 0 | 3.71 |
| 2020-09 | 0 | 3.21 |
| 2020-10 | 0 | 3.89 |
| 2020-11 | 0 | 4.39 |
| 2020-12 | 0 | 4.48 |
| 2021-01 | 0 | 3.62 |
| 2021-02 | 0 | 3.65 |
| 2021-03 | 0 | 3 |
| 2021-04 | 0 | 3.29 |
| 2021-05 | 0 | 3.35 |
| 2021-06 | 0 | 2.53 |
| 2021-07 | 0 | 2.68 |
| 2021-08 | 0 | 3.19 |
| 2021-09 | 0 | 4 |
| 2021-10 | 0 | 4 |
| 2021-11 | 0 | 4.62 |
| 2021-12 | 0 | 4.36 |
| 2022-01 | 0 | 4.08 |
| 2022-02 | 0 | 5.7 |
| 2022-03 | 0 | 4.5 |
| 2022-04 | 0 | 2.69 |
| 2022-05 | 0 | 2.38 |
| 2022-06 | 0 | 3.81 |
| 2022-07 | 0 | 3.17 |
| 2022-08 | 0 | 1.84 |
| 2022-09 | 0 | 2.82 |
| 2022-10 | 0 | 3.67 |
| 2022-11 | 0 | 1.77 |
| 2022-12 | 0 | 3.07 |
| 2023-01 | 0 | 2.73 |
| 2023-02 | 0 | 2.82 |
| 2023-03 | 0 | 2.85 |
| 2023-04 | 0 | 2.62 |
| 2023-05 | 0 | 2.88 |
| 2023-06 | 0 | 3.52 |
| 2023-07 | 0 | 2.31 |
| 2023-08 | 0 | 3.3 |
| 2023-09 | 0 | 2.5 |
| 2023-10 | 0 | 3.17 |
| 2023-11 | 0 | 3.07 |
| 2023-12 | 0 | 2.79 |
| 2024-01 | 0 | 2.65 |
| 2024-02 | 0 | 3.08 |
| 2024-03 | 0 | 2.45 |
| 2024-04 | 0 | 3.24 |
| 2024-05 | 0 | 2.7 |
| 2024-06 | 0 | 1.73 |
| 2024-07 | 0 | 2.53 |
| 2024-08 | 0 | 3.2 |
| 2024-09 | 0 | 2.36 |
| 2024-10 | 0 | 2.81 |
| 2024-11 | 0 | 2.44 |
| 2024-12 | 0 | 2.55 |
| 2025-01 | 0 | 1.89 |
| 2025-02 | 0 | 2.82 |
| 2025-03 | 0 | 1.65 |
| 2025-04 | 0 | 3.24 |
| 2025-05 | 0 | 2 |
| 2025-06 | 0 | 2.68 |
| 2025-07 | 0 | 2.21 |
| 2025-08 | 0 | 1.5 |
| 2025-09 | 0 | 1.88 |
| 2025-10 | 0 | 2.43 |
| 2025-11 | 0 | 1.6 |
| 2025-12 | 0 | 2.35 |
| 2026-01 | 0 | 1.94 |
| 2026-02 | 0 | 2 |
| 2026-03 | 0 | 1.76 |
| 2026-04 | 0 | 4.18 |
| 2026-05 | 0 | 3.5 |
| 2026-06 | 0 | 2.58 |
Regulatory clearances
- K251015 SESE 2025-04-30 (k number procode)
Predicate lineage
K251015 — cites (transitively): K232971 (d1), K173841 (d2), K223545 (d2), K090752 (d3), K151667 (d3), K160449 (d3), K170329 (d3), K142458 (d3), K173200 (d3), K072718 (d4), K100769 (d4), K113163 (d4), K133317 (d4), K090335 (d4), K110483 (d4), K114083 (d4), K133177 (d4), K051758 (d4), K122756 (d4), K151623 (d4), K152541 (d4), K130123 (d4), K150134 (d4), K080583 (d5), K011725 (d5), K021368 (d5), K032802 (d5), K051749 (d5), K063336 (d5)
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — Alembic, LLC
Nothing in the loaded window.