Nexiva Closed IV Catheter System with NearPort IV Access
Summary
Becton Dickinson Infusion Therapy Systems, Inc. received 510(k) clearance for Nexiva Closed IV Catheter System with NearPort IV Access, a FOZ device. Cleared on 2023-09-22.
Details
Source
510(k) Clearance
External ID
K231239
Action Date
2023-09-22
Status
Traditional
Category
device
Product Code
FOZ
Product Description
Nexiva Closed IV Catheter System with NearPort IV Access. Product code: FOZ.
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 403 device clearances issued this month. Becton Dickinson Infusion Therapy Systems, Inc. has received 10 total clearances in our database.
Becton Dickinson Infusion Therapy Systems, Inc. has 25 FDA actions in our database, including 15 recalls and 10 clearances.
Frequently Asked Questions
What does 510(k) clearance mean?
A 510(k) is an FDA premarket submission demonstrating that a device is substantially equivalent to a legally marketed device. It does NOT mean FDA approval — it means the device is cleared for marketing because it's similar enough to an existing cleared device. Most medical devices reach market via 510(k) rather than full PMA approval.
How often does Becton Dickinson Infusion Therapy Systems, Inc. have FDA actions?
Becton Dickinson Infusion Therapy Systems, Inc. has 25 FDA actions in our database, including 15 recalls and 10 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K231239" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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