LWE

Bone Marrow Collection/Transfusion Kit

Product code

LWE

Device name

Bone Marrow Collection/Transfusion Kit

Device class

Class 2

Medical specialty

Unknown

Marketing pathway

Enforcement Discretion

510(k) clearances (last 3 years)

3

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).