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., B.Braun Medical, Inc. and Poly Medicure Limited.
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
503 total 510(k) submissions under product code FOZ since 1976, with 503 receiving FDA clearance (average review time: 142 days).
Submission volume has remained relatively stable over the observed period, with 17 submissions in the last 24 months.
FDA Review Time
FDA review times for FOZ submissions have been consistent, averaging 142 days recently vs 142 days historically.
FOZ devices are reviewed by the General Hospital panel. Browse all General Hospital devices →