FDA Product Code FOZ: Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Under FDA product code FOZ, short-term intravascular therapeutic catheters are cleared for the delivery of medications and fluids directly into the vascular system.
These catheters provide temporary vascular access for the administration of drugs, fluids, blood products, or parenteral nutrition over periods of days to weeks. They include peripheral and central venous catheters used across inpatient and outpatient settings.
FOZ devices are Class II medical devices, regulated under 21 CFR 880.5200 and reviewed by the FDA General Hospital panel.
Leading manufacturers include Becton Dickinson Infusion Therapy Systems, Inc., Bd Becton Dickinson Vacutainer Systems Preanalytic and C.R. Bard, Inc..
FDA 510(k) Cleared Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days Devices (Product Code FOZ)
About Product Code FOZ - Regulatory Context
510(k) Submission Activity
504 total 510(k) submissions under product code FOZ since 1976, with 504 receiving FDA clearance (average review time: 142 days).
Submission volume has increased in recent years - 18 submissions in the last 24 months compared to 14 in the prior period - suggesting growing market activity in this device classification.
FDA 510(k) Review Time - FOZ Product Code
FDA review times for FOZ submissions have been consistent, averaging 147 days recently vs 142 days historically.
FOZ devices are reviewed by the General Hospital panel. Browse all General Hospital devices →