Submission Details
| 510(k) Number | K233529 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 02, 2023 |
| Decision Date | December 01, 2023 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Special
BD Nexiva? Diffusics? Closed IV Catheter System with BD MaxZero? Needle-free Connector
Dec 2023
Decision
29d
Days
Class 2
Risk
About This 510(k) Submission
K233529 is an FDA 510(k) clearance for the BD Nexiva? Diffusics? Closed IV Catheter System with BD MaxZero? Needle-free Connector, 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 December 1, 2023, 29 days after receiving the submission on November 2, 2023. 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
Becton Dickinson Infusion Therapy Systems, Inc.
Sandy, UT · US
Sunny Patel
35 submissions
35 cleared
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