DYBFDA Class 2 · 21 CFR 870.1340
Introducer, Catheter
Device family · Cardiovascular
Automated profile from regulatory + adverse-event registries · AI-reviewed · expert clinical sign-off in progress — not yet independently verified.
FDA clearances
700
Manufacturers
106
Flagged signals
23
Adverse-event reports
32,967
Code matrix
| FDA product code | DYB |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1340 |
| GMDN | — (crosswalk pending) |
| Implantable | No |
| Life-sustaining | No |
Adverse-event signals
Public · always freeMAUDE disproportionality (PRR), flagged where PRR ≥ 2, χ² ≥ 4, count ≥ 3.
| Event type | Year | Reports | PRR | χ² |
|---|---|---|---|---|
| Other | 2010 | 4 | 45.1 | 131 |
| Death | 2025 | 4 | 25.2 | 71 |
| Other | 2010 | 9 | 19.0 | 136 |
| Death | 2025 | 6 | 15.1 | 66 |
| Other | 2010 | 4 | 13.3 | 34 |
| Death | 2015 | 5 | 13.2 | 45 |
| Death | 2026 | 12 | 9.7 | 85 |
| Other | 2009 | 3 | 6.3 | 9 |
| Death | 2014 | 8 | 5.7 | 27 |
| Death | 2015 | 3 | 5.4 | 7 |
| Death | 2024 | 106 | 3.3 | 165 |
| Death | 2025 | 5 | 3.0 | 5 |
| Death | 2025 | 89 | 2.7 | 97 |
| Death | 2023 | 89 | 2.7 | 97 |
| Death | 2023 | 27 | 2.7 | 28 |
| Death | 2025 | 10 | 2.4 | 7 |
| Death | 2022 | 75 | 2.3 | 55 |
| Death | 2021 | 22 | 2.2 | 14 |
| Death | 2022 | 22 | 2.2 | 14 |
| Death | 2024 | 22 | 2.2 | 14 |
| Injury | 2022 | 173 | 2.1 | 154 |
| Injury | 2023 | 7 | 2.0 | 4 |
| Death | 2025 | 15 | 2.0 | 7 |
Device-level recall linkage pending an FDA-recalls product-code re-ingest. Class 2 family · 32,967 total adverse-event reports.
Manufacturer landscape
| Manufacturer | Clearances | Latest | Concern |
|---|---|---|---|
| St Jude Medical | 21 | 2014 | — |
| Terumo Medical Corp. | 19 | 2011 | — |
| Cordis Corp. | 19 | 2000 | — |
| Daig Corp. | 18 | 2000 | — |
| Merit Medical Systems, Inc. | 18 | 2025 | — |
| COOK INCORPORATED | 17 | 2021 | 0.23 |
| C.R. Bard, Inc. | 16 | 2021 | — |
| Oscor, Inc. | 13 | 2021 | — |
| Arrow Intl., Inc. | 9 | 2002 | — |
| B.Braun Medical, Inc. | 9 | 2004 | — |
| Edwards Lifesciences, LLC | 8 | 2014 | — |
| TERUMO MEDICAL CORPORATION | 8 | 2020 | — |
| Boston Scientific Corp | 8 | 2015 | — |
| W. L. Gore & Associates, Inc. | 7 | 2016 | — |
| Great Batch Medical | 7 | 2018 | — |
| Abiomed, Inc. | 6 | 2025 | — |
| Norton Performance Plastics Corp. | 6 | 1983 | — |
| Medtronic Vascular | 6 | 2016 | — |
| ACUTUS MEDICAL, INC. | 6 | 2023 | — |
| BOSTON SCIENTIFIC CORPORATION | 6 | 2023 | 0.14 |
| ARGON MEDICAL DEVICES, INC. | 6 | 2025 | — |
| Quinton, Inc. | 5 | 1987 | — |
| Datascope Corp. | 5 | 2000 | — |
| ACCESS SCIENTIFIC, LLC | 5 | 2019 | — |
| ST. JUDE MEDICAL, INC. | 5 | 2016 | — |
Concern score lights up where a maker maps to a scored entity (depth fast-follow).
Recent FDA clearances
Introducer Sheath Set · Cardiocycle Medical(Suzhou) Co., Ltd.510(k) · 2026-04-23
Edwards eSheath+ introducer set · Edwards Lifesciences510(k) · 2026-04-17
Aventus Introducer Sheath · Inquis Medical510(k) · 2026-04-13
Protaryx Transseptal Puncture Device (PTX2-001) · Protaryx Medical, Inc.510(k) · 2026-04-10
AuST Steerable Sheath · CenterPoint Systems, LLC510(k) · 2026-04-07
VANES Delivery System (VDS) · Zoll Respicardia, Inc.510(k) · 2026-04-06
Multiflex Steerable Sheath 17.5F · Vizaramed, Inc.510(k) · 2026-03-26
AuST CSP Introducer · CenterPoint Systems, LLC510(k) · 2026-02-19
Peel-Away Introducer Sheath · VascuTech Medical, LLC510(k) · 2026-02-09
Genie MAX Large Bore Introducer Sheath · Cultiv8 1, LLC510(k) · 2026-01-22
Intri26 Introducer Sheath · Inari Medical, Inc.510(k) · 2025-12-17
VStick Vascular Access Set · Argon Medical Devices, Inc.510(k) · 2025-12-15
PerQseal Introducers · Vivasure Medical Limited510(k) · 2025-10-23
Introducer Sheath Set · Cardiocycle Medical(Suzhou) Co., Ltd.510(k) · 2025-10-21
14Fr Low Profile Introducer Kit · Abiomed, Inc.510(k) · 2025-10-08
Primero Safe Access System · South53, LLC510(k) · 2025-09-29
Pounce(TM) Sheath · Surmodics,Inc.510(k) · 2025-09-24
Vertex(TM) Catheter · Jupiter Endovascular510(k) · 2025-09-12
Edwards eSheath Optima introducer set · Edwards Lifesciences510(k) · 2025-08-29
AuST Steerable Sheath · CenterPoint Systems, LLC510(k) · 2025-04-30
Prelude Wave Hydrophilic Sheath Introducer · Merit Medical Systems, Inc.510(k) · 2025-04-25
PeriCross Epicardial Access Kit · Circa Scientific, Inc.510(k) · 2025-04-24
Edwards eSheath Optima introducer set · Edwards Lifesciences510(k) · 2025-03-27
iSLEEVE Introducer Set · Boston Scientific510(k) · 2025-03-20
ViaOne Epicardial Access System · Cardiovia , Ltd.510(k) · 2025-03-20
Sources: FDA 510(k)/PMA · openFDA MAUDE · FDA device classification · MedevIQ manufacturer-canonical. Registry data, AI-reviewed; expert clinical sign-off in progress.