Submission Details
| 510(k) Number | K243403 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 31, 2024 |
| Decision Date | July 25, 2025 |
| Days to Decision | 267 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Traditional
BD Nexiva? Closed IV Catheter System
Jul 2025
Decision
267d
Days
Class 2
Risk
About This 510(k) Submission
K243403 is an FDA 510(k) clearance for the BD Nexiva? Closed IV Catheter System, a Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (Class II — Special Controls, product code FOZ), submitted by Becton Dickinson Infusion Therapy Systems, Inc. (Sandy, US). The FDA issued a Cleared decision on July 25, 2025, 267 days after receiving the submission on October 31, 2024. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5200.
Device Classification
| Product Code | FOZ — Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 880.5200 |
Manufacturer
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