FDA product code DQT: Occluder, Catheter Tip
DQT is the FDA product code for occluder, catheter tip. It is a Class II device, regulated under 21 CFR 870.1370 and reviewed by the Cardiovascular panel. FDA has cleared 12 510(k) submissions under DQT, from 10 different applicants. The average 510(k) review took 109 days (median 116). FDA has posted 4 recalls for DQT devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Occluder, Catheter Tip |
| Device class | Class II |
| Regulation | 21 CFR 870.1370 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every DQT clearance
Top DQT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ideas For Medicine, Inc. | 3 | 1988-05-25 |
| Arterial Vascular Engineering, Inc. | 1 | 1999-03-11 |
| Micro Interventional Systems, Inc. | 1 | 1995-02-08 |
| Cathlab Corp. | 1 | 1991-06-24 |
| Applied Vascular Devices, Inc. | 1 | 1991-05-29 |
5 more applicants have DQT clearances. See the full list in Caduvo.
Most recent DQT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K983927 | Arterial Vascular Engineering, Inc. | GT1 FLOPPY, GT1 HI-PER FLEX, GT1 LIGHT SUPPORT | 1999-03-11 | 126 |
| K945963 | Micro Interventional Systems, Inc. | THE OMNIGUIDE GUIDING CATHETER WITH BALLOON | 1995-02-08 | 63 |
| K910916 | Cathlab Corp. | CATHLAB SILICONE OCCLUSION BALLOON CATHETER | 1991-06-24 | 111 |
| K910339 | Applied Vascular Devices, Inc. | AVD INTIMAX OCCLUSION CATHETER | 1991-05-29 | 121 |
| K880860 | Dlp, Inc. | CORONARY OSTIUM OCCLUDER, CATALOG CODE 32015 | 1988-05-26 | 86 |
Recalls for DQT devices
4 product recalls in 3 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2025-04-11.
| Year | Recalls |
|---|---|
| 2025 | 1 |
Frequently asked questions
What is FDA product code DQT?
DQT is the FDA product code for occluder, catheter tip. It is a Class II device, regulated under 21 CFR 870.1370 and reviewed by the Cardiovascular panel.
What device class is DQT?
Class II, regulation 21 CFR 870.1370. Typical premarket route: 510(k).
How long does a 510(k) take for product code DQT?
Across 12 cleared submissions the average was 109 days from receipt to decision (median 116).
Which companies have the most DQT clearances?
Ideas For Medicine, Inc. (3); Arterial Vascular Engineering, Inc. (1); Micro Interventional Systems, Inc. (1); Cathlab Corp. (1); Applied Vascular Devices, Inc. (1).
Have DQT devices been recalled?
Yes: 4 product recalls across 3 recall events; the most recent began 2025-04-11.
Next steps
- Run an FDA pathway report with predicate devices for product code DQT
- Run a recall and safety report across every DQT manufacturer
- Watch product code DQT 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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