BSO
- Product code
- BSO
- Device name
- Catheter, Conduction, Anesthetic
- Device class
- Class 2
- 21 CFR
- 21 CFR 868.5120
- Medical specialty
- Anesthesiology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 75
510(k) clearances, last 3 years (2)
| Number | Decision date | Applicant | Device name |
|---|---|---|---|
| K241410 | 2025-02-13 | Jmt Co., Ltd. | EDEN ControlCath summary |
| K231242 | 2023-09-15 | B.Braun Medical, Inc. | Perifix FX Catheter; Contiplex FX Catheter summary |
Official FDA classification page: BSO
Classification and pathway per current FDA publications. Data from openFDA (CC0).