FDA Product Code PSQ: Intracardiac Patch Or Pledget, Biologically Derived
To Repair Defects, To Be Used For Patch Grafting, To Repair Tissue, And To Buttress Sutures In The Heart And Vasculature.
11
Total
11
Cleared
152d
Avg days
2017
Since
Declining activity -
0 submissions in the last 2 years
vs 2 in the prior period
FDA 510(k) Cleared Intracardiac Patch Or Pledget, Biologically Derived Devices (Product Code PSQ)
11 devices
No devices found for this product code.
About Product Code PSQ - Regulatory Context
510(k) Submission Activity
11 total 510(k) submissions under product code PSQ since 2017, with 11 receiving FDA clearance (average review time: 152 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.