OFL

Percutaneous Sheath Introducer Kit

Product code

OFL

Device name

Percutaneous Sheath Introducer Kit

Device class

Class 2

21 CFR

21 CFR 870.1340

Medical specialty

Cardiovascular

Marketing pathway

Enforcement Discretion

FDA classification definition

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).