CentroVena Central Venous Catheter (CVC) with the CentroVena One Insertion System
FDA 510(k) clearance K242429 · decided 2025-04-09
Clearance details
- K-number
- K242429
- Device name
- CentroVena Central Venous Catheter (CVC) with the CentroVena One Insertion System
- Applicant
- Becton Dickinson Inc. (Bd)
- Decision
- Substantially Equivalent
- Date received
- 2024-08-15
- Decision date
- 2025-04-09
- Days to decision
- 237 days
- Clearance type
- Traditional
- Product code
- SEF
- Device class
- 2
- Regulation number
- 880.5200
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Salt Lake Ciy,, UT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.