HiPoint 88 reperfusion catheter with Tenzing 8
Model Gen 1 · ROUTE 92 MEDICAL · DI 00853799007961
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
- K243601 SESE 2025-05-19 (k number procode)
Predicate lineage
K243601 — cites (transitively): K191717 (d1), K191768 (d1), K201518 (d1), K203043 (d1), K223530 (d1), K240529 (d1), K142819 (d2), K152876 (d2), K172167 (d2), K181354 (d2), K190212 (d2), K200121 (d2), K161064 (d2), K222743 (d2), K091329 (d3), K984500 (d3), K111380 (d3), K152541 (d3), K152202 (d3), K171672 (d3), K173841 (d3), K180169 (d3), K180201 (d3), K190431 (d3), K210635 (d3), K070970 (d4), K082290 (d4), K122772 (d4), K142458 (d4), K110055 (d4), K090752 (d4), K151667 (d4), K160449 (d4), K170329 (d4), K150107 (d4), K161152 (d4), K163233 (d4), K182512 (d4), K093970 (d5), K072718 (d5), K100769 (d5), K113163 (d5), K133317 (d5), K090335 (d5), K110483 (d5), K114083 (d5), K133177 (d5), K051758 (d5), K122756 (d5), K151623 (d5), K130123 (d5), K150134 (d5), K080583 (d6), K011725 (d6), K021368 (d6), K032802 (d6), K051749 (d6), K063336 (d6) — cited as predicate by K253590
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — ROUTE 92 MEDICAL
Nothing in the loaded window.