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"EXEL SAFETY PSV SET 25G X 3/4"", 12"" TUBE"
Model 27808 · Exel International · DI 00020221278088
FOZ — Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days · Class II · 21 CFR 880.5200
FPA — Set, Administration, Intravascular · Class II · 21 CFR 880.5440
UDILibrary device dossier · generated 2026-09-06 · 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
4.01
2019-02
0
3.65
2019-03
0
4.19
2019-04
0
4.63
2019-05
0
3.55
2019-06
0
3.23
2019-07
0
3.66
2019-08
0
3.76
2019-09
0
3.41
2019-10
0
3.6
2019-11
0
3.18
2019-12
0
3.42
2020-01
0
3.31
2020-02
0
3.46
2020-03
0
3.55
2020-04
0
4.09
2020-05
0
3.9
2020-06
0
3.85
2020-07
0
3.33
2020-08
0
3.8
2020-09
0
3.51
2020-10
0
2.95
2020-11
0
3.46
2020-12
0
3.46
2021-01
0
3.33
2021-02
0
3.36
2021-03
0
2.86
2021-04
0
3.02
2021-05
0
3.7
2021-06
0
4.11
2021-07
0
4.21
2021-08
0
3.67
2021-09
0
3.14
2021-10
0
3.17
2021-11
0
4.22
2021-12
0
4.17
2022-01
0
4.58
2022-02
0
3.72
2022-03
0
3.72
2022-04
0
4.19
2022-05
0
4.65
2022-06
0
4.41
2022-07
0
3.48
2022-08
0
3.71
2022-09
0
4.56
2022-10
0
3.66
2022-11
0
3.29
2022-12
0
3.27
2023-01
0
3.97
2023-02
0
3.33
2023-03
0
3.77
2023-04
0
3.01
2023-05
0
3.64
2023-06
0
3.4
2023-07
0
3.26
2023-08
0
3.61
2023-09
0
3.17
2023-10
0
3.1
2023-11
0
3.2
2023-12
0
2.85
2024-01
0
2.85
2024-02
0
3.26
2024-03
0
2.72
2024-04
0
3.44
2024-05
0
12.25
2024-06
0
35.91
2024-07
0
37.27
2024-08
0
25.9
2024-09
0
20.76
2024-10
0
16.33
2024-11
0
17.52
2024-12
0
12.9
2025-01
0
11
2025-02
0
8.94
2025-03
0
10.44
2025-04
0
9.26
2025-05
0
11.07
2025-06
0
7.4
2025-07
0
7.28
2025-08
0
7.59
2025-09
0
6.16
2025-10
0
6.96
2025-11
0
8.71
2025-12
0
5.61
2026-01
0
7.05
2026-02
0
6.44
2026-03
0
27.47
2026-04
0
62.56
2026-05
0
53.47
2026-06
0
59.97
This device (reports/month)Average device in FOZ, FPA (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — Exel International