DRAClass II
Catheter, Steerable
21 CFR 870.1280 / Cardiovascular
DRA is the FDA product code for Catheter, Steerable, a class II device type, regulated under 21 CFR 870.1280. As of , FDA records hold 42 510(k) clearances under this code, the most recent dated , and 10 recalls.
Classification record
- Product code
- DRA
- Device name
- Catheter, Steerable
- Regulation
- 21 CFR 870.1280
- Device class
- Class II
- Review panel
- Cardiovascular
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 42
- Ingested recalls
- 10
Clearances, product code DRA
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1984 | 1 |
| 1989 | 1 |
| 1990 | 1 |
| 1991 | 1 |
| 1993 | 2 |
| 2001 | 1 |
| 2004 | 1 |
| 2005 | 1 |
| 2006 | 1 |
| 2007 | 1 |
| 2008 | 1 |
| 2009 | 2 |
| 2010 | 3 |
| 2011 | 1 |
| 2012 | 4 |
| 2014 | 1 |
| 2015 | 1 |
| 2016 | 4 |
| 2017 | 2 |
| 2018 | 1 |
| 2019 | 2 |
| 2020 | 1 |
| 2021 | 1 |
| 2022 | 2 |
| 2023 | 3 |
| 2025 | 1 |
| 2026 | 1 |
Applicants with the most clearances
Product code DRA| Applicant | Clearances |
|---|---|
| Medtronic CryoCath LP | 6 |
| Hansen Medical, Inc. | 5 |
| Catheter Research C/O Burditt, Bowles & Radzius | 4 |
| Evalve, Inc. | 4 |
| Abbott Medical | 4 |
| Abbott Vascular | 3 |
| Acutus Medical, Inc. | 3 |
| Boston Scientific Corporation | 3 |
| CardioFocus, Inc. | 1 |
| Cardiosolutions, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.