FIRST PICC CATHETER— 510(k) K972262
Substantially EquivalentBecton Dickinson Infusion Therapy Systems, Inc.
FDA 510(k) clearance K972262 for FIRST PICC CATHETER, Substantially Equivalent on 1997-09-15. 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- 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
- K250682 — BD Nexiva Diffusics Closed IV Catheter System and BD Nexiva Diffusics Closed IV Catheter System with BD MaxZero Needle-free Connector
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.