APRO 70 Catheter
Model APRO-70-135 · Alembic, LLC · DI 00850014025014
NRY — Catheter, Thrombus Retriever · Class II · 21 CFR 870.1250
UDILibrary device dossier · generated 2026-09-13 · 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
- K230695 SESE 2023-04-10 (k number procode)
- K223545 SESE 2023-02-17 (k number procode)
Predicate lineage
K223545 — cites (transitively): K142458 (d1), K173200 (d1), K072718 (d2), K090752 (d2), K100769 (d2), K113163 (d2), K133317 (d2), K152541 (d2) — cited as predicate by K230695, K232971, K234115, K243287, K243297
K230695 — cites (transitively): K223545 (d1), K142458 (d2), K173200 (d2), K072718 (d3), K090752 (d3), K100769 (d3), K113163 (d3), K133317 (d3), K152541 (d3)
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — Alembic, LLC
Nothing in the loaded window.