QTF

Reprocessed Atherectomy Catheter

Product code

QTF

Device name

Reprocessed Atherectomy Catheter

Device class

Class 2

21 CFR

21 CFR 870.4875

Medical specialty

Cardiovascular

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification definition

Reprocessed atherectomy device for peripheral vasculature. Reprocessing validation data for this device type must be included in a 510(k) submission

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