Septostomy Catheter, Reprocessed

FDA product code QLZ · Class II (moderate risk) · 21 CFR 870.5175 · Cardiovascular

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

2510(k) clearances
0PMA approvals
0recalls
GMP exemptexempt from GMP rules

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K213584Reprocessed NRG Transseptal NeedleQLZ · Traditional Innovative Health, LLC04/04/2023SE
K200060Reprocessed NRG Transseptal NeedleQLZ · Traditional Innovative Health, LLC07/30/2020SE