QLZ

Septostomy Catheter, Reprocessed

Product code

QLZ

Device name

Septostomy Catheter, Reprocessed

Device class

Class 2

21 CFR

21 CFR 870.5175

Medical specialty

Cardiovascular

Marketing pathway

510(K)

Flag

GMP exempt

510(k) clearances (all years, FDA)

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

FDA classification definition

To create or enlarge an atrial septal defect in the heart.

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