The same device (matched on an identical UDI-DI) is registered in other jurisdictions. EU coverage (EUDAMED) is still phasing in — absence here does not mean a device is not marketed there.
- European UnionAVANTI™+ Transradial Introducer Kit 07050320000000000000011C6
Read this first: 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 shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 1 |
| 2019-02 | 0 | 1 |
| 2019-03 | 0 | 2.4 |
| 2019-04 | 0 | 2 |
| 2019-05 | 0 | 1.78 |
| 2019-06 | 0 | 1.5 |
| 2019-07 | 0 | 1.5 |
| 2019-08 | 0 | 1.45 |
| 2019-09 | 0 | 3 |
| 2019-10 | 0 | 1.33 |
| 2019-11 | 0 | 3.88 |
| 2019-12 | 0 | 1.33 |
| 2020-01 | 0 | 1.67 |
| 2020-02 | 0 | 1.86 |
| 2020-03 | 0 | 1.5 |
| 2020-04 | 0 | 1.75 |
| 2020-05 | 0 | 1.83 |
| 2020-06 | 0 | 4.75 |
| 2020-07 | 0 | 2.25 |
| 2020-08 | 0 | 1.33 |
| 2020-09 | 0 | 1.8 |
| 2020-10 | 0 | 1.6 |
| 2020-11 | 0 | 1.3 |
| 2020-12 | 0 | 1.8 |
| 2021-01 | 0 | 1.75 |
| 2021-02 | 0 | 1.5 |
| 2021-03 | 0 | 1.5 |
| 2021-04 | 0 | 2.17 |
| 2021-05 | 0 | 1.5 |
| 2021-06 | 0 | 3 |
| 2021-07 | 0 | 2.6 |
| 2021-08 | 0 | 3.33 |
| 2021-09 | 0 | 3 |
| 2021-10 | 0 | 1 |
| 2021-11 | 0 | 1.4 |
| 2021-12 | 0 | 1.86 |
| 2022-01 | 0 | 1.14 |
| 2022-02 | 0 | 1.45 |
| 2022-03 | 0 | 2.69 |
| 2022-04 | 0 | 1 |
| 2022-05 | 0 | 2.45 |
| 2022-06 | 0 | 1.67 |
| 2022-07 | 0 | 1.67 |
| 2022-08 | 0 | 1.67 |
| 2022-09 | 0 | 1.91 |
| 2022-10 | 0 | 1.4 |
| 2022-11 | 0 | 1.5 |
| 2022-12 | 0 | 1.78 |
| 2023-01 | 0 | 1.4 |
| 2023-02 | 0 | 1.67 |
| 2023-03 | 0 | 2.62 |
| 2023-04 | 0 | 1.91 |
| 2023-05 | 0 | 2.3 |
| 2023-06 | 0 | 2.55 |
| 2023-07 | 0 | 3.8 |
| 2023-08 | 0 | 2.95 |
| 2023-09 | 0 | 4.67 |
| 2023-10 | 0 | 2.17 |
| 2023-11 | 0 | 3.36 |
| 2023-12 | 0 | 3.32 |
| 2024-01 | 0 | 2.31 |
| 2024-02 | 0 | 3.25 |
| 2024-03 | 0 | 2.45 |
| 2024-04 | 0 | 2.29 |
| 2024-05 | 0 | 3.27 |
| 2024-06 | 0 | 3.14 |
| 2024-07 | 0 | 1.81 |
| 2024-08 | 0 | 2.18 |
| 2024-09 | 0 | 2.57 |
| 2024-10 | 0 | 2.26 |
| 2024-11 | 0 | 2.25 |
| 2024-12 | 1 | 1.86 |
| 2025-01 | 0 | 2.15 |
| 2025-02 | 0 | 3.63 |
| 2025-03 | 0 | 2.71 |
| 2025-04 | 0 | 1.84 |
| 2025-05 | 0 | 2.05 |
| 2025-06 | 0 | 2.7 |
| 2025-07 | 0 | 3.32 |
| 2025-08 | 0 | 2.62 |
| 2025-09 | 0 | 1.85 |
| 2025-10 | 0 | 3.06 |
| 2025-11 | 0 | 1.86 |
| 2025-12 | 0 | 2.14 |
| 2026-01 | 0 | 2.2 |
| 2026-02 | 0 | 2.24 |
| 2026-03 | 0 | 3.11 |
| 2026-04 | 0 | 2.44 |
| 2026-05 | 0 | 5.14 |
| 2026-06 | 0 | 2.31 |
No recalls linked.
Predicate lineage
Cited as predicate by: K110051
Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2022-06-29 | VAI | Voluntary action indicated | Cordis US Corp | 0 |
| 2022-06-29 | VAI | Voluntary action indicated | Cordis US Corp | 0 |
| 2018-01-12 | VAI | Voluntary action indicated | Cordis US Corp | 1 |
| 2018-01-12 | VAI | Voluntary action indicated | Cordis US Corp | 1 |
| 2017-09-15 | VAI | Voluntary action indicated | AccessClosure, Inc., A Cardinal Health Company | 1 |
| 2016-07-06 | NAI | No action indicated | Cordis US Corp | 0 |
| 2016-07-06 | NAI | No action indicated | Cordis US Corp | 0 |
| 2016-03-31 | NAI | No action indicated | Cordis US Corp | 0 |
| 2016-03-31 | NAI | No action indicated | Cordis US Corp | 0 |
| 2016-02-12 | VAI | Voluntary action indicated | Cardinal Health Mexico 244 S de RL de CV | 3 |
| 2016-02-01 | NAI | No action indicated | AccessClosure, Inc., A Cardinal Health Company | 0 |
| 2015-05-08 | NAI | No action indicated | Cordis US Corp | 0 |
| 2015-05-08 | NAI | No action indicated | Cordis US Corp | 0 |
| 2014-08-05 | VAI | Voluntary action indicated | AccessClosure, Inc., A Cardinal Health Company | 3 |
| 2014-04-03 | NAI | No action indicated | Cardinal Health Mexico 244 S de RL de CV | 0 |
| 2014-01-30 | NAI | No action indicated | Cordis US Corp | 0 |
| 2014-01-30 | NAI | No action indicated | Cordis US Corp | 0 |
| 2013-12-18 | NAI | No action indicated | Cordis US Corp | 0 |
| 2013-12-18 | NAI | No action indicated | Cordis US Corp | 0 |
| 2012-07-03 | NAI | No action indicated | Cordis US Corp | 0 |
| 2011-02-16 | WL | Warning Letter | Cordis LLC | — |
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