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
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.
QLZ devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →