FDA Product Code CAZ: Anesthesia Conduction Kit
This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. This Type Of Convenience Kit, As Listed In The Guidance Above, Is Under Enforcement Discretion, And Does Not Require A Premarket Notification (510(k)) To Market If It Meets All Criteria In The Guidance.
Leading manufacturers include Bd Becton Dickinson Vacutainer Systems Preanalytic, Medtronic Vascular and PAJUNK GmbH Medizintechnologie.
FDA 510(k) Cleared Anesthesia Conduction Kit Devices (Product Code CAZ)
About Product Code CAZ - Regulatory Context
510(k) Submission Activity
155 total 510(k) submissions under product code CAZ since 1976, with 155 receiving FDA clearance (average review time: 129 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.