FDA product code DQR: Cannula, Catheter
DQR is the FDA product code for cannula, catheter. It is a Class II device, regulated under 21 CFR 870.1300 and reviewed by the Cardiovascular panel. FDA has cleared 25 510(k) submissions under DQR, from 20 different applicants. The average 510(k) review took 96 days (median 83). FDA has posted 26 recalls for DQR devices, 6 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Cannula, Catheter |
| Device class | Class II |
| Regulation | 21 CFR 870.1300 |
| 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 DQR clearance
Top DQR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Shiley, Inc. | 3 | 1990-03-28 |
| Research Medical, Inc. | 2 | 1996-03-26 |
| Harbor Medical Devices, Inc. | 2 | 1989-05-15 |
| Medsurg Industries, Inc. | 2 | 1988-05-03 |
| Integra LifeSciences Corporation | 1 | 2013-10-28 |
15 more applicants have DQR clearances. See the full list in Caduvo.
Most recent DQR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K131446 | Integra LifeSciences Corporation | INTEGRA JARIT HEPARIN CANNULAS, INJECTORS, AND NEEDLES | 2013-10-28 | 161 |
| K073559 | Edwards Lifesciences Research Medical | 18 FR. RMI ARTERIAL PERFUSION CANNULA II, 20 FR. RMI ARTERIAL PERFUSION CANNULA II | 2008-01-31 | 43 |
| K051655 | AngioDynamics, Inc. | ANGIODYNAMICS, INC., MICRO ACCESS KITS | 2005-09-12 | 83 |
| K030398 | Cardiacassist, Inc. | CARDIACASSIST TRANSSEPTAL CANNULA SET, MODEL 5132-6221 | 2003-05-23 | 106 |
| K960098 | Research Medical, Inc. | RMI INTERNAL MAMMARY ARTERY CANNULA | 1996-03-26 | 75 |
Recalls for DQR devices
26 product recalls in 5 recall events; 6 initiated in the last five years and 6 still open. Most recent: 2025-05-14.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2020 | 1 |
| 2025 | 6 |
Frequently asked questions
What is FDA product code DQR?
DQR is the FDA product code for cannula, catheter. It is a Class II device, regulated under 21 CFR 870.1300 and reviewed by the Cardiovascular panel.
What device class is DQR?
Class II, regulation 21 CFR 870.1300. Typical premarket route: 510(k).
How long does a 510(k) take for product code DQR?
Across 25 cleared submissions the average was 96 days from receipt to decision (median 83).
Which companies have the most DQR clearances?
Shiley, Inc. (3); Research Medical, Inc. (2); Harbor Medical Devices, Inc. (2); Medsurg Industries, Inc. (2); Integra LifeSciences Corporation (1).
Have DQR devices been recalled?
Yes: 26 product recalls across 5 recall events; the most recent began 2025-05-14.
Next steps
- Run an FDA pathway report with predicate devices for product code DQR
- Run a recall and safety report across every DQR manufacturer
- Watch product code DQR 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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