DeviceClearance

Product code QLZ— Cardiovascular

Reprocessed NRG Transseptal Needle

Classification name
Septostomy Catheter, Reprocessed
Device class
Class 2
Regulation
21 CFR 870.5175
Advisory panel
Cardiovascular
Total cleared
2
First cleared
Most recent

FDA classification definition

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

— U.S. Food and Drug Administration, device classification record for product code QLZ under 21 CFR 870.5175, via openFDA

Market context for product code QLZ

FDA has cleared 2 devices under product code QLZ between 2020 and 2023, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QLZ

Recent clearances under product code QLZ

Data sourced from openFDA. This site is unofficial and independent of the FDA.