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70 NeuGlide Catheter
Model 100898-002 · PIRAEUS MEDICAL INC. · DI 00860015527738
DQY — Catheter, Percutaneous · Class II · 21 CFR 870.1250
QJP — Catheter, Percutaneous, Neurovasculature · Class II · 21 CFR 870.1250
UDILibrary device dossier · generated 2026-10-20 · 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.
Monthly adverse-event reports for this device versus the product-code average.
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
1.55
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
2.53
2021-02
0
2.5
2021-03
0
2.38
2021-04
0
2.04
2021-05
0
2.7
2021-06
0
2.42
2021-07
0
2
2021-08
0
2.47
2021-09
0
2.02
2021-10
0
2.28
2021-11
0
1.9
2021-12
0
2.19
2022-01
0
2.17
2022-02
0
2.14
2022-03
0
1.83
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
3.13
2025-01
0
3.09
2025-02
0
2.85
2025-03
0
2.78
2025-04
0
2.53
2025-05
0
2.7
2025-06
0
3.34
2025-07
0
3.46
2025-08
0
3.05
2025-09
0
3.04
2025-10
0
3.28
2025-11
0
3.49
2025-12
0
4.04
2026-01
0
3.93
2026-02
0
3.45
2026-03
0
3.42
2026-04
0
3.22
2026-05
0
3.55
2026-06
0
3.63
2026-07
0
2.77
2026-08
0
3.34
2026-09
0
3.07
This device (reports/month)Average device in DQY, QJP (reports/device/month)
Regulatory clearances
K262277 SESE 2026-09-04 (k number procode)
Manufacturer compliance record — PIRAEUS MEDICAL INC.