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QLZ — Septostomy Catheter, Reprocessed Class II

FDA Device Classification

Classification Details

Product Code
QLZ
Device Class
Class II
Regulation Number
870.5175
Submission Type
Review Panel
CV
Medical Specialty
Cardiovascular
Implant
No

Definition

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

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K213584innovative healthReprocessed NRG Transseptal NeedleApril 4, 2023
K200060innovative healthReprocessed NRG Transseptal NeedleJuly 30, 2020