K242429 is an FDA 510(k) clearance for the CentroVena Central Venous Catheter (CVC) with the CentroVena One Insertion System. This device is classified as a Central Venous Catheter With Manual Insertion System (Class II - Special Controls, product code SEF).
Submitted by Becton Dickinson Inc. (Bd) (Salt Lake Ciy,, US). The FDA issued a Cleared decision on April 9, 2025, 237 days after receiving the submission on August 15, 2024.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5200. 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) Number | K242429 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 15, 2024 |
| Decision Date | April 09, 2025 |
| Days to Decision | 237 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | SEF - Central Venous Catheter With Manual Insertion System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5200 |
| 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. |