DQXFDA Class 2 · 21 CFR 870.1330
Wire, Guide, 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
763
Manufacturers
90
Flagged signals
17
Adverse-event reports
25,301
Code matrix
| FDA product code | DQX |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1330 |
| 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 | 2012 | 5 | 17.1 | 61 |
| Death | 2025 | 5 | 16.2 | 58 |
| Death | 2026 | 4 | 13.0 | 33 |
| Death | 2020 | 5 | 12.6 | 43 |
| Death | 2012 | 3 | 9.7 | 16 |
| Death | 2023 | 4 | 7.2 | 16 |
| Death | 2020 | 8 | 5.5 | 25 |
| Death | 2022 | 8 | 5.5 | 25 |
| Death | 2021 | 7 | 4.8 | 18 |
| Death | 2019 | 7 | 4.8 | 18 |
| Death | 2025 | 7 | 4.8 | 18 |
| Death | 2023 | 6 | 4.1 | 11 |
| Death | 2010 | 5 | 4.0 | 8 |
| Death | 2018 | 5 | 3.4 | 6 |
| Death | 2017 | 5 | 3.4 | 6 |
| Injury | 2022 | 5 | 2.6 | 6 |
| Injury | 2024 | 4 | 2.6 | 4 |
Device-level recall linkage pending an FDA-recalls product-code re-ingest. Class 2 family · 25,301 total adverse-event reports.
Manufacturer landscape
| Manufacturer | Clearances | Latest | Concern |
|---|---|---|---|
| ASAHI INTECC CO., LTD. | 47 | 2025 | — |
| Advanced Cardiovascular Systems, Inc. | 45 | 2002 | — |
| Lake Region Mfg., Inc. | 31 | 2010 | — |
| Scimed Life Systems, Inc. | 30 | 1998 | — |
| Cordis Corp. | 25 | 2004 | — |
| Guidant Corp. | 25 | 2006 | — |
| Boston Scientific Corp | 23 | 2014 | — |
| Target Therapeutics | 22 | 1997 | — |
| Merit Medical Systems, Inc. | 22 | 2024 | — |
| COOK INCORPORATED | 14 | 2019 | 0.23 |
| Lake Region Medical | 12 | 2026 | — |
| Abbott Vascular | 12 | 2020 | — |
| Cook, Inc. | 12 | 2013 | — |
| C.R. Bard, Inc. | 11 | 1999 | — |
| Datascope Corp. | 10 | 2000 | — |
| Terumo Medical Corp. | 10 | 2008 | — |
| BOSTON SCIENTIFIC CORPORATION | 9 | 2018 | 0.14 |
| Vascular Solutions, Inc. | 8 | 2018 | — |
| Stereotaxis, Inc. | 8 | 2014 | — |
| Abbott Vascular, Inc. | 7 | 2014 | — |
| VOLCANO CORPORATION | 7 | 2021 | — |
| Micro Therapeutics, Inc. | 6 | 2012 | — |
| Arrow Intl., Inc. | 6 | 2004 | — |
| Medtronic, Inc. | 5 | 2025 | — |
| Meadox Medicals, Div. Boston Scientific Corp. | 5 | 1995 | — |
Concern score lights up where a maker maps to a scored entity (depth fast-follow).
Recent FDA clearances
FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40; FMD Peripheral Guide Wire F-18 Flex SP; FMD Peripheral Guide Wire F-18 DP 25; FMD Peripheral Guide Wire F-18 Tapered 40 · FMD Co., Ltd.510(k) · 2026-03-20
Enroute 0.014'' Transcarotid Guidewire · Lake Region Medical510(k) · 2026-03-19
EmeryGlide (EG18008901) · Nano4imaging GmbH510(k) · 2026-03-06
Splashwire Hydrophilic Guide Wire (MSWSTD35150J3) · Merit Medical Ireland, Ltd.510(k) · 2026-01-31
InQwire Super Stiff Guide Wire (IQSS32180J3); InQwire Super Stiff Guide Wire (IQSS35F260S); InQwire Super Stiff Guide Wire (IQSS35F150S); InQwire Super Stiff Guide Wire (IQSS35F100S); InQwire Super Stiff Guide Wire (IQSS35F80S); InQwire Super Stiff Guide Wire (IQSS35F180S) · Merit Medical Ireland, Ltd.510(k) · 2026-01-21
Solo Pace Fusion System (SOLOFUSE1) · Solo Pace, Inc.510(k) · 2026-01-09
Lunderquist Extra Stiff Wire Guide · William Cook Europe Aps510(k) · 2025-11-09
SureAx-Guide · Sureax Medical, LLC510(k) · 2025-10-17
Amplatzer Guidewire · ABBOTT MEDICAL510(k) · 2025-10-03
Splashwire Hydrophilic Guide Wire (MSWSTD35180J1O5); Splashwire Hydrophilic Guide Wire (MSWSTD35260J1O5); Splashwire Hydrophilic Guide Wire (MSWSTDA35150LT); Splashwire Hydrophilic Guide Wire (MSWSTFA35260LT); Splashwire Hydrophilic Guide Wire (MSWSTFA35150LT); Splashwire Hydrophilic Guide Wire (MSWSTFS38150LT) · Merit Medical Ireland, Ltd.510(k) · 2025-08-29
Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire · ABBOTT MEDICAL510(k) · 2025-07-25
Medtronic Stedi Extra Support Guidewire · Medtronic, Inc.510(k) · 2025-06-13
SION blue PLUS · Asahi Intecc Co., Ltd.510(k) · 2025-04-02
Crossloop · Asahi Intecc Co., Ltd.510(k) · 2025-03-27
CROSSLEAD 0.018inch · Asahi Intecc Co., Ltd.510(k) · 2025-03-05
CROSSLEAD 0.014inch · Asahi Intecc Co., Ltd.510(k) · 2025-02-06
Prelude Small O.D. Introducer Guide Wire · Merit Medical Systems, Inc.510(k) · 2024-12-10
PTFE Guidewire · Lake Region Medical510(k) · 2024-12-06
R2P Radifocus Glidewire Advantage · Terumo Corporation510(k) · 2024-11-26
Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire · ABBOTT MEDICAL510(k) · 2024-11-06
Arrow® Nitinol Wire · Teleflex Medical510(k) · 2024-09-18
Glidewire GT-R · Terumo Corporation510(k) · 2024-08-21
CROSSLEAD Tracker · Asahi Intecc Co., Ltd.510(k) · 2024-08-14
MINAMO blue; MINAMO viola · Asahi Intecc Co., Ltd.510(k) · 2024-06-21
FMD Peripheral Guide Wire F-18 Flex 400 (CSU415400259) · FMD Co., Ltd.510(k) · 2024-06-13
Sources: FDA 510(k)/PMA · openFDA MAUDE · FDA device classification · MedevIQ manufacturer-canonical. Registry data, AI-reviewed; expert clinical sign-off in progress.