FDA product code DQY: Catheter, Percutaneous
DQY is the FDA product code for catheter, percutaneous. It is a Class II device, regulated under 21 CFR 870.1250 and reviewed by the Cardiovascular panel. FDA has cleared 896 510(k) submissions under DQY, 84 in the last five years, from 279 different applicants. The average 510(k) review took 104 days (median 85); 100 days on average over the last three years. FDA has posted 620 recalls for DQY devices, 46 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Catheter, Percutaneous |
| Device class | Class II |
| Regulation | 21 CFR 870.1250 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for DQY
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 26 | 116 |
| 2018 | 25 | 122 |
| 2019 | 30 | 131 |
| 2020 | 20 | 147 |
| 2021 | 18 | 112 |
| 2022 | 18 | 112 |
| 2023 | 18 | 114 |
| 2024 | 16 | 109 |
| 2025 | 21 | 120 |
| 2026 | 11 | 70 |
Compare with all 510(k) review times · Search every DQY clearance
Top DQY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medtronic Vascular | 31 | 2023-08-22 |
| Biotronik, Inc. | 23 | 2024-09-12 |
| Vascular Solutions, Inc. | 21 | 2018-04-04 |
| Cordis Corp. | 21 | 2002-06-13 |
| Cook, Inc. | 20 | 2014-01-29 |
274 more applicants have DQY clearances. See the full list in Caduvo.
Most recent DQY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K262817 | Vantis Vascular, Inc. | CrossFAST Integrated Microcatheter Advanced Delivery System | 2026-09-18 | 42 |
| K260559 | IMDS Operation B.V. | NHanceIT | 2026-08-14 | 176 |
| K262392 | Alembic, LLC | APRO 35 Swift Catheter | 2026-08-12 | 29 |
| K262240 | CenterPoint Systems, LLC | SSPC NXT Delivery Catheter | 2026-07-29 | 28 |
| K261766 | CenterPoint Systems, LLC | CPS Locator 3D Plus Delivery Catheter | 2026-07-29 | 62 |
Recalls for DQY devices
620 product recalls in 127 recall events; 46 initiated in the last five years and 45 still open. Most recent: 2026-04-30.
| Year | Recalls |
|---|---|
| 2017 | 16 |
| 2018 | 20 |
| 2019 | 197 |
| 2020 | 4 |
| 2021 | 13 |
| 2022 | 3 |
| 2023 | 19 |
| 2024 | 6 |
| 2025 | 15 |
| 2026 | 2 |
Frequently asked questions
What is FDA product code DQY?
DQY is the FDA product code for catheter, percutaneous. It is a Class II device, regulated under 21 CFR 870.1250 and reviewed by the Cardiovascular panel.
What device class is DQY?
Class II, regulation 21 CFR 870.1250. Typical premarket route: 510(k).
How long does a 510(k) take for product code DQY?
Across 896 cleared submissions the average was 104 days from receipt to decision (median 85).
Which companies have the most DQY clearances?
Medtronic Vascular (31); Biotronik, Inc. (23); Vascular Solutions, Inc. (21); Cordis Corp. (21); Cook, Inc. (20).
Have DQY devices been recalled?
Yes: 620 product recalls across 127 recall events; the most recent began 2026-04-30.
Next steps
- Run an FDA pathway report with predicate devices for product code DQY
- Run a recall and safety report across every DQY manufacturer
- Watch product code DQY 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.
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