BD Nexiva and BD Nexiva Diffusics Closed IV Catheter Systems— 510(k) K161777
Substantially EquivalentBecton Dickinson Infusion Therapy Systems, Inc.
FDA 510(k) clearance K161777 for BD Nexiva and BD Nexiva Diffusics Closed IV Catheter Systems, Substantially Equivalent on 2016-08-29. Applicant: Becton Dickinson Infusion Therapy Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Becton Dickinson Infusion Therapy Systems, Inc.
- Product code
- Code FOZ
- Device class
- Class 2
- Regulation
- 21 CFR 880.5200
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sandy, UT, US
Recent devices under product code FOZ
view allMore clearances from Becton Dickinson Infusion Therapy Systems, Inc.
view all- K252137 — BD Insyte IV Catheter
- K251422 — BD Saf-T-Intima Subcutaneous Catheter System
- K243403 — BD Nexiva Closed IV Catheter System
- K251155 — BD Cathena Safety IV Catheter
- K251654 — BD Insyte Autoguard Shielded IV Catheter, BD Insyte Autoguard BC Shielded IV Catheter and BD Insyte Autoguard BC Pro Shielded IV Catheter
Adverse events under product code FOZ
product code FOZ- Death
- 38
- Injury
- 2,290
- Malfunction
- 25,858
- Other
- 11
- Total
- 28,197
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K161777
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K161777.
Data sourced from openFDA. This site is unofficial and independent of the FDA.