FDA Product Code QLZ: Septostomy Catheter, Reprocessed
To Create Or Enlarge An Atrial Septal Defect In The Heart.
Leading manufacturers include Innovative Health, LLC.
2
Total
2
Cleared
354d
Avg days
2020
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Septostomy Catheter, Reprocessed Devices (Product Code QLZ)
2 devices
Cleared
Apr 04, 2023
Reprocessed NRG Transseptal Needle
Innovative Health, LLC
Cardiovascular
508d
Cleared
Jul 30, 2020
Reprocessed NRG Transseptal Needle
Innovative Health, LLC
Cardiovascular
199d
About Product Code QLZ - Regulatory Context
510(k) Submission Activity
2 total 510(k) submissions under product code QLZ since 2020, with 2 receiving FDA clearance (average review time: 354 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.