Print-ready dossier — use your browser's print dialog to save as PDF.
ACCEL®
Model 612137 · B BRAUN INTERVENTIONAL SYSTEMS, INC · DI 04046955237487
DRE — Dilator, Vessel, For Percutaneous Catheterization · Class II · 21 CFR 870.1310
KGZ — Accessories, Catheter · Class I · 21 CFR 878.4200
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
2.29
2019-02
0
1.4
2019-03
0
2.5
2019-04
0
2.33
2019-05
0
2.08
2019-06
0
1.33
2019-07
0
1.63
2019-08
0
1.54
2019-09
0
2.91
2019-10
0
1.45
2019-11
0
3.56
2019-12
0
1.83
2020-01
0
2.09
2020-02
0
2.1
2020-03
0
1.55
2020-04
0
1.78
2020-05
0
2.38
2020-06
0
4.09
2020-07
0
2.09
2020-08
0
1.5
2020-09
0
4.5
2020-10
0
1.83
2020-11
0
1.33
2020-12
0
1.92
2021-01
0
2.14
2021-02
0
2.4
2021-03
0
1.8
2021-04
0
2.46
2021-05
0
3
2021-06
0
2.82
2021-07
0
3.14
2021-08
0
5
2021-09
0
2.8
2021-10
0
1
2021-11
0
2
2021-12
0
1.86
2022-01
0
1.13
2022-02
0
1.57
2022-03
0
3.73
2022-04
0
1
2022-05
0
2.63
2022-06
0
4
2022-07
0
2.45
2022-08
0
1.83
2022-09
0
2.75
2022-10
0
3.33
2022-11
0
3.33
2022-12
0
1.91
2023-01
0
2.13
2023-02
0
1.55
2023-03
0
2.5
2023-04
0
2.08
2023-05
0
2.38
2023-06
0
2.69
2023-07
0
3.55
2023-08
0
2.86
2023-09
0
3.44
2023-10
0
2.17
2023-11
0
3.8
2023-12
0
3.13
2024-01
0
2.21
2024-02
0
2.87
2024-03
0
2.5
2024-04
0
2.26
2024-05
0
3.59
2024-06
0
3.13
2024-07
0
1.86
2024-08
0
2.16
2024-09
0
2.68
2024-10
0
2.45
2024-11
0
2.43
2024-12
0
1.91
2025-01
0
2.13
2025-02
0
3.53
2025-03
0
2.75
2025-04
0
2.09
2025-05
0
2.09
2025-06
0
2.5
2025-07
0
3.35
2025-08
0
2.53
2025-09
0
1.93
2025-10
0
2.94
2025-11
0
1.96
2025-12
0
2.17
2026-01
0
2.23
2026-02
0
2.25
2026-03
0
2.87
2026-04
0
2.5
2026-05
0
4.64
2026-06
0
2.36
This device (reports/month)Average device in DRE, KGZ (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — B BRAUN INTERVENTIONAL SYSTEMS, INC