SEFClass II
Central Venous Catheter With Manual Insertion System
21 CFR 880.5200 / General Hospital
SEF is the FDA product code for Central Venous Catheter With Manual Insertion System, a class II device type, regulated under 21 CFR 880.5200. FDA's definition for this code reads: "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". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.
Classification record
- Product code
- SEF
- Device name
- Central Venous Catheter With Manual Insertion System
- FDA 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.
- Regulation
- 21 CFR 880.5200
- Device class
- Class II
- Review panel
- General Hospital
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 1
- Ingested recalls
- 0
Clearances, product code SEF
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2025 | 1 |
Applicants with the most clearances
Product code SEF| Applicant | Clearances |
|---|---|
| Becton Dickinson Inc. (BD) | 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.