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4 Fr PV Catheter
Model CA-41103-PN · CD Leycom · DI 08719327737316
DQO — Catheter, Intravascular, Diagnostic · Class II · 21 CFR 870.1200
OBJ — Catheter, Ultrasound, Intravascular · Class II · 21 CFR 870.1200
UDILibrary device dossier · generated 2026-09-15 · 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
1.76
2019-02
0
1.85
2019-03
0
2.11
2019-04
0
2.14
2019-05
0
1.5
2019-06
0
1.73
2019-07
0
1.91
2019-08
0
2.94
2019-09
0
1.83
2019-10
0
2.33
2019-11
0
2.16
2019-12
0
2.05
2020-01
0
2.54
2020-02
0
2.06
2020-03
0
2.37
2020-04
0
1.97
2020-05
0
1.8
2020-06
0
2.39
2020-07
0
2.26
2020-08
0
2.19
2020-09
0
1.85
2020-10
0
1.85
2020-11
0
1.75
2020-12
0
2.43
2021-01
0
1.71
2021-02
0
2.3
2021-03
0
1.85
2021-04
0
2.37
2021-05
0
1.82
2021-06
0
1.7
2021-07
0
2.61
2021-08
0
2.57
2021-09
0
2.1
2021-10
0
2.76
2021-11
0
2.3
2021-12
0
1.95
2022-01
0
2
2022-02
0
2.53
2022-03
0
2.77
2022-04
0
2.66
2022-05
0
2.16
2022-06
0
2.71
2022-07
0
2
2022-08
0
2.33
2022-09
0
2.68
2022-10
0
5.13
2022-11
0
2.65
2022-12
0
2.41
2023-01
0
2.8
2023-02
0
2.17
2023-03
0
3.6
2023-04
0
2.55
2023-05
0
2.58
2023-06
0
2.38
2023-07
0
2.9
2023-08
0
2.78
2023-09
0
2.12
2023-10
0
2.45
2023-11
0
3.07
2023-12
0
3.11
2024-01
0
4.43
2024-02
0
3.08
2024-03
0
2.91
2024-04
0
3.16
2024-05
0
3.35
2024-06
0
3.13
2024-07
0
2.81
2024-08
0
2.39
2024-09
0
2.79
2024-10
0
2.51
2024-11
0
2.78
2024-12
0
3.25
2025-01
0
3.31
2025-02
0
3.09
2025-03
0
3
2025-04
0
2.45
2025-05
0
3.64
2025-06
0
3.42
2025-07
0
3.9
2025-08
0
2.93
2025-09
0
4.93
2025-10
0
4.07
2025-11
0
4.04
2025-12
0
5.06
2026-01
0
5.56
2026-02
0
4.35
2026-03
0
4.21
2026-04
0
4.2
2026-05
0
3.89
2026-06
0
4.42
This device (reports/month)Average device in DQO, OBJ (reports/device/month)