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87 NeuGlide Catheter
Model 103577-004 · PIRAEUS MEDICAL INC. · DI 00860010306321
DQY — Catheter, Percutaneous · Class II · 21 CFR 870.1250
QJP — Catheter, Percutaneous, Neurovasculature · Class II · 21 CFR 870.1250
UDILibrary device dossier · generated 2026-09-05 · 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
2.63
2019-02
0
1.91
2019-03
0
1.82
2019-04
0
2.35
2019-05
0
1.76
2019-06
0
1.91
2019-07
0
2.49
2019-08
0
1.97
2019-09
0
1.58
2019-10
0
2.69
2019-11
0
1.94
2019-12
0
2.02
2020-01
0
2.82
2020-02
0
2.03
2020-03
0
2.19
2020-04
0
2.62
2020-05
0
1.99
2020-06
0
2.29
2020-07
0
3.14
2020-08
0
2.25
2020-09
0
2.24
2020-10
0
3.08
2020-11
0
2.29
2020-12
0
2.59
2021-01
0
2.52
2021-02
0
2.5
2021-03
0
2.38
2021-04
0
2.08
2021-05
0
2.71
2021-06
0
2.43
2021-07
0
2.04
2021-08
0
2.48
2021-09
0
2.07
2021-10
0
2.3
2021-11
0
1.93
2021-12
0
2.22
2022-01
0
2.17
2022-02
0
2.16
2022-03
0
1.84
2022-04
0
2.22
2022-05
0
1.87
2022-06
0
2.26
2022-07
0
2.05
2022-08
0
2.38
2022-09
0
2.11
2022-10
0
2.17
2022-11
0
2.06
2022-12
0
1.9
2023-01
0
1.79
2023-02
0
1.94
2023-03
0
1.98
2023-04
0
2.16
2023-05
0
1.85
2023-06
0
2.11
2023-07
0
2.06
2023-08
0
1.95
2023-09
0
1.96
2023-10
0
2.34
2023-11
0
2.45
2023-12
0
2.35
2024-01
0
1.87
2024-02
0
2.07
2024-03
0
1.87
2024-04
0
1.91
2024-05
0
1.95
2024-06
0
2.16
2024-07
0
1.97
2024-08
0
1.94
2024-09
0
2.1
2024-10
0
2.3
2024-11
0
2.44
2024-12
0
3.03
2025-01
0
2.83
2025-02
0
2.8
2025-03
0
2.68
2025-04
0
2.47
2025-05
0
2.59
2025-06
0
3.11
2025-07
0
3.29
2025-08
0
2.76
2025-09
0
2.93
2025-10
0
3.19
2025-11
0
3.19
2025-12
0
3.69
2026-01
0
3.44
2026-02
0
3.28
2026-03
0
3.2
2026-04
0
3.06
2026-05
0
3.39
2026-06
0
3.33
This device (reports/month)Average device in DQY, QJP (reports/device/month)