FDA product code SEF: Central Venous Catheter With Manual Insertion System
SEF is the FDA product code for central venous catheter with manual insertion system. It is a Class II device, regulated under 21 CFR 880.5200 and reviewed by the General Hospital panel. FDA has cleared 1 510(k) submission under SEF, 1 in the last five years. The average 510(k) review took 237 days (median 237); 237 days on average over the last three years.
Definition
A central venous catheter with manual insertion system is intended to provide short-term access (<30 days) to the central venous system. The manual insertion system is attached to the catheter and facilitates placement in the targeted vessel.
Classification
| Field | Value |
|---|---|
| Device name | Central Venous Catheter With Manual Insertion System |
| Device class | Class II |
| Regulation | 21 CFR 880.5200 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
510(k) clearances per year for SEF
| Year | Clearances | Avg. review days |
|---|---|---|
| 2025 | 1 | 237 |
Compare with all 510(k) review times · Search every SEF clearance
Top SEF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Becton Dickinson Inc. (Bd) | 1 | 2025-04-09 |
Most recent SEF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K242429 | Becton Dickinson Inc. (Bd) | CentroVena Central Venous Catheter (CVC) with the CentroVena One Insertion System | 2025-04-09 | 237 |
Recalls for SEF devices
openFDA lists no recalls for product code SEF.
Frequently asked questions
What is FDA product code SEF?
SEF is the FDA product code for central venous catheter with manual insertion system. It is a Class II device, regulated under 21 CFR 880.5200 and reviewed by the General Hospital panel.
What device class is SEF?
Class II, regulation 21 CFR 880.5200. Typical premarket route: 510(k).
How long does a 510(k) take for product code SEF?
Across 1 cleared submissions the average was 237 days from receipt to decision (median 237).
Which companies have the most SEF clearances?
Becton Dickinson Inc. (Bd) (1).
Next steps
- Run an FDA pathway report with predicate devices for product code SEF
- Run a recall and safety report across every SEF manufacturer
- Watch product code SEF 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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