FDA product code DRA: Catheter, Steerable
DRA is the FDA product code for catheter, steerable. It is a Class II device, regulated under 21 CFR 870.1280 and reviewed by the Cardiovascular panel. FDA has cleared 41 510(k) submissions under DRA, 6 in the last five years, from 22 different applicants. The average 510(k) review took 104 days (median 80); 99 days on average over the last three years. FDA has posted 6 recalls for DRA devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Catheter, Steerable |
| Device class | Class II |
| Regulation | 21 CFR 870.1280 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for DRA
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 99 |
| 2018 | 1 | 10 |
| 2019 | 2 | 74 |
| 2020 | 1 | 64 |
| 2021 | 1 | 31 |
| 2022 | 2 | 82 |
| 2023 | 3 | 85 |
| 2025 | 1 | 99 |
Top DRA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medtronic Cryocath, LP | 4 | 2020-11-13 |
| Evalve, Inc. | 4 | 2010-04-21 |
| Catheter Research C/O Burditt, Bowles & Radzius | 4 | 1993-06-29 |
| Acutus Medical, Inc. | 3 | 2022-05-05 |
| Abbott Vascular | 3 | 2017-09-06 |
17 more applicants have DRA clearances. See the full list in Caduvo.
Most recent DRA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K250529 | Kardium, Inc. | Globe Introducer (601-01001) | 2025-06-03 | 99 |
| K233248 | Boston Scientific Corporation | FARADRIVE Steerable Sheath | 2023-12-11 | 74 |
| K232321 | Medtronic, Inc. | FlexCath Contour Steerable Sheath | 2023-10-31 | 89 |
| K223824 | Boston Scientific Corporation | POLARSHEATH Steerable Sheath 12F (UPN:M004CRBS3150), POLARMAP Circular Mapping Catheter (UPN:M004CRBS7210), POLARMAP EP Electrical Cable (UPN:M004CRBS62000), SMARTFREEZE Esophageal Temperature Sensor (ETS) Cable: -SMARTFREEZE Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6310), -SMARTFREEZE 16 PIN Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6320), -SMARTFREEZE CIRCA Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6340), SMARTFREEZE Pressure Sensor | 2023-03-22 | 91 |
| K221397 | ABBOTT MEDICAL | MitraClip G4 Steerable Guide Catheter | 2022-09-28 | 138 |
Recalls for DRA devices
6 product recalls in 5 recall events; 1 initiated in the last five years and 3 still open. Most recent: 2024-02-12.
| Year | Recalls |
|---|---|
| 2021 | 2 |
| 2024 | 1 |
Frequently asked questions
What is FDA product code DRA?
DRA is the FDA product code for catheter, steerable. It is a Class II device, regulated under 21 CFR 870.1280 and reviewed by the Cardiovascular panel.
What device class is DRA?
Class II, regulation 21 CFR 870.1280. Typical premarket route: 510(k).
How long does a 510(k) take for product code DRA?
Across 41 cleared submissions the average was 104 days from receipt to decision (median 80).
Which companies have the most DRA clearances?
Medtronic Cryocath, LP (4); Evalve, Inc. (4); Catheter Research C/O Burditt, Bowles & Radzius (4); Acutus Medical, Inc. (3); Abbott Vascular (3).
Have DRA devices been recalled?
Yes: 6 product recalls across 5 recall events; the most recent began 2024-02-12.
Next steps
- Run an FDA pathway report with predicate devices for product code DRA
- Run a recall and safety report across every DRA manufacturer
- Watch product code DRA 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.