Central Venous Catheter With Manual Insertion System
A central venous catheter with manual insertion system is a hospital device intended to provide short-term central venous access (less than 30 days), incorporating a manual insertion system attached to the catheter to facilitate placement in the targeted central vessel for infusion of fluids, medications, or monitoring of central venous pressure. It is classified as FDA Class II (510(k) required) under regulation 880.5200 in the General Hospital specialty, with product code SEF. The device is not an implant and does not support life-sustaining functions.
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Basic Information
- Product Code
- SEF
- Device Class
- FDA class 2
- Regulation Number
- 880.5200
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K242429 | CentroVena Central Venous Catheter (CVC) with the CentroVena One Insertion System | Apr 09, 2025 | Substantially Equivalent | Becton Dickinson Inc. (Bd) |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.