Device type

Peripheral Catheter Insertion Kit

Product code OWL · Class II · 21 CFR 880.5200 · General Hospital

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 kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.

FDA classification database