MFY

Endothelial Cell Harvesting Kit

Product code

MFY

Device name

Endothelial Cell Harvesting Kit

Device class

Class 2

21 CFR

21 CFR 870.4075

Medical specialty

Cardiovascular

Marketing pathway

Enforcement Discretion

510(k) clearances (last 3 years)

1

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).