DRA
- Product code
- DRA
- Device name
- Catheter, Steerable
- Device class
- Class 2
- 21 CFR
- 21 CFR 870.1280
- Medical specialty
- Cardiovascular
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 4
- Summaries archived here
- 2 (direct download)
- 510(k) clearances (all years, FDA)
- 42 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (4)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K262165 | 2026-07-24 | Boston Scientific Corporation | FARADRIVE Steerable Sheath (M004PF21M402) | FDA |
| K250529 | 2025-06-03 | Kardium, Inc. | Globe Introducer (601-01001) | |
| K233248 | 2023-12-11 | Boston Scientific Corporation | FARADRIVE Steerable Sheath | |
| K232321 | 2023-10-31 | Medtronic, Inc. | FlexCath Contour Steerable Sheath | FDA |
Official FDA classification page: DRA
Classification and pathway per current FDA publications. Data from openFDA (CC0).