OFC · Class II · 21 CFR 870.1340

FDA Product Code OFC: Catheter Introducer 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.

1
Total
1
Cleared
158d
Avg days
2010
Since

FDA 510(k) Cleared Catheter Introducer Kit Devices (Product Code OFC)

1 devices
1–1 of 1
No devices found for this product code.

About Product Code OFC - Regulatory Context