FDA product code DQX: Wire, Guide, Catheter
DQX is the FDA product code for wire, guide, catheter. It is a Class II device, regulated under 21 CFR 870.1330 and reviewed by the Cardiovascular panel. FDA has cleared 768 510(k) submissions under DQX, 57 in the last five years, from 216 different applicants. The average 510(k) review took 116 days (median 89); 165 days on average over the last three years. FDA has posted 258 recalls for DQX devices, 52 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Wire, Guide, Catheter |
| Device class | Class II |
| Regulation | 21 CFR 870.1330 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for DQX
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 19 | 91 |
| 2018 | 19 | 144 |
| 2019 | 13 | 147 |
| 2020 | 14 | 98 |
| 2021 | 6 | 158 |
| 2022 | 15 | 204 |
| 2023 | 10 | 174 |
| 2024 | 11 | 146 |
| 2025 | 10 | 195 |
| 2026 | 11 | 154 |
Compare with all 510(k) review times · Search every DQX clearance
Top DQX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Asahi Intecc Co., Ltd. | 47 | 2025-04-02 |
| Advanced Cardiovascular Systems, Inc. | 45 | 2002-01-24 |
| Lake Region Mfg., Inc. | 31 | 2010-02-26 |
| Scimed Life Systems, Inc. | 30 | 1998-11-12 |
| Guidant Corp. | 25 | 2006-06-22 |
211 more applicants have DQX clearances. See the full list in Caduvo.
Most recent DQX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253146 | Rapid-Medical , Ltd. | Hyperdrive 35 Guidewire | 2026-09-18 | 358 |
| K261281 | Filmecc Co., Ltd. | CROSSLEAD Standard 035 and CROSSLEAD Stiff 035 | 2026-09-03 | 139 |
| K253667 | Sp Medical A/S | Accoat Guide Wire | 2026-07-14 | 235 |
| K261640 | Merit Medical Ireland , Ltd. | Merit MAK Nitinol/Gold-Tungsten Guide Wire | 2026-07-13 | 56 |
| K254137 | Merit Medical Ireland, Ltd. | InQwire Amplatz Guide Wire | 2026-05-22 | 151 |
Recalls for DQX devices
258 product recalls in 73 recall events; 52 initiated in the last five years and 54 still open. Most recent: 2026-06-26.
| Year | Recalls |
|---|---|
| 2017 | 25 |
| 2018 | 15 |
| 2019 | 4 |
| 2020 | 1 |
| 2022 | 35 |
| 2024 | 9 |
| 2025 | 1 |
| 2026 | 7 |
Frequently asked questions
What is FDA product code DQX?
DQX is the FDA product code for wire, guide, catheter. It is a Class II device, regulated under 21 CFR 870.1330 and reviewed by the Cardiovascular panel.
What device class is DQX?
Class II, regulation 21 CFR 870.1330. Typical premarket route: 510(k).
How long does a 510(k) take for product code DQX?
Across 768 cleared submissions the average was 116 days from receipt to decision (median 89).
Which companies have the most DQX clearances?
Asahi Intecc Co., Ltd. (47); Advanced Cardiovascular Systems, Inc. (45); Lake Region Mfg., Inc. (31); Scimed Life Systems, Inc. (30); Guidant Corp. (25).
Have DQX devices been recalled?
Yes: 258 product recalls across 73 recall events; the most recent began 2026-06-26.
Next steps
- Run an FDA pathway report with predicate devices for product code DQX
- Run a recall and safety report across every DQX manufacturer
- Watch product code DQX for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Cardiovascular product codes · FDA product code lookup · 510(k) database search · 510(k) review times