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ALN Straight RS
Model FT.902010 · A.L.N. · DI 03760017680103
DTK — Filter, Intravascular, Cardiovascular · Class II · 21 CFR 870.3375
UDILibrary device dossier · generated 2026-09-12 · 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
6.5
2019-02
0
4.38
2019-03
0
8.1
2019-04
0
10.93
2019-05
0
6.82
2019-06
0
7.85
2019-07
0
11.53
2019-08
0
9.71
2019-09
0
14.71
2019-10
0
11.63
2019-11
0
9.77
2019-12
0
9.6
2020-01
0
17.29
2020-02
0
14.6
2020-03
0
9.91
2020-04
0
14.76
2020-05
0
5.29
2020-06
0
7.86
2020-07
0
19.07
2020-08
0
7.11
2020-09
0
7
2020-10
0
26.67
2020-11
0
9.5
2020-12
0
8.95
2021-01
0
11.38
2021-02
0
18.95
2021-03
0
11.24
2021-04
0
9.75
2021-05
0
8
2021-06
0
14.19
2021-07
0
11.14
2021-08
0
8.06
2021-09
0
7.27
2021-10
0
6.26
2021-11
0
9.09
2021-12
0
8.44
2022-01
0
5.14
2022-02
0
4.74
2022-03
0
4.86
2022-04
0
6
2022-05
0
11.64
2022-06
0
4.77
2022-07
0
4.36
2022-08
0
4.7
2022-09
0
4
2022-10
0
3.17
2022-11
0
1.83
2022-12
0
4.44
2023-01
0
3.69
2023-02
0
3.4
2023-03
0
3.6
2023-04
0
2.83
2023-05
0
4
2023-06
0
7.22
2023-07
0
3.8
2023-08
0
3
2023-09
0
2.08
2023-10
0
3.78
2023-11
0
2.67
2023-12
0
4.78
2024-01
0
1.6
2024-02
0
3.2
2024-03
0
3.5
2024-04
0
3.57
2024-05
0
2.5
2024-06
0
4.17
2024-07
0
2.4
2024-08
0
3.14
2024-09
0
3
2024-10
0
2.83
2024-11
0
2.38
2024-12
0
4.4
2025-01
0
1.5
2025-02
0
1.57
2025-03
0
3.6
2025-04
0
1.57
2025-05
0
4.33
2025-06
0
4.2
2025-07
0
3.14
2025-08
0
2.75
2025-09
0
3.57
2025-10
0
3.8
2025-11
0
3.6
2025-12
0
2.83
2026-01
0
3.5
2026-02
0
4.2
2026-03
0
6.2
2026-04
0
2.25
2026-05
0
3.33
2026-06
0
2.25
This device (reports/month)Average device in DTK (reports/device/month)
Regulatory clearances
K163699 SESE 2017-09-08 (k number procode)
Predicate lineage
K163699 — cited as predicate by K241507
Lineage extracted from public 510(k) summary text (heuristic).