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.
Leading manufacturers include Admedus Regen Pty, Ltd., Cryolife, Inc. and Synovis Life Technologies, Inc..
11
Total
11
Cleared
152d
Avg days
2017
Since
Stable submission activity - 0 submissions in the last 2 years
FDA 510(k) Cleared Intracardiac Patch Or Pledget, Biologically Derived Devices (Product Code PSQ)
11 devices
Cleared
Oct 19, 2022
PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair Patch
Synovis Life Technologies, Inc.
Cardiovascular
195d
Cleared
Oct 19, 2022
Vascu-Guard Vascular Repair Patch
Synovis Life Technologies, Inc.
Cardiovascular
195d
Cleared
Dec 21, 2021
CardiaMend Pericardial and Epicardial Reconstruction Matrix
Helios Cardio, Inc.
Cardiovascular
319d
Cleared
Apr 03, 2020
ADAPT Tissue
Admedus Regen Pty, Ltd.
Cardiovascular
30d
Cleared
Feb 13, 2020
XenoSure Biologic Patch
Lemaitre Vascular
General & Plastic Surgery
315d
Cleared
Nov 22, 2019
MatriStem UBM Pericardial Patch
Acell, Inc.
Cardiovascular
147d
Cleared
Feb 14, 2019
PhotoFix Decellularized Bovine Pericardium
Cryolife, Inc.
Cardiovascular
50d
Cleared
Oct 10, 2018
CorMatrix Cor Patch (3 cm x 5 cm)(single pack), CorMatrix Cor Patch (4 cm x 7 cm)(single pack), CorMatrix Cor Patch (7 cm x 10 cm)(single pack)
Cormatrix Cardiovascular, Inc.
Cardiovascular
174d
Cleared
Dec 04, 2017
PhotoFix Decellularized Bovine Pericardium
Cryolife, Inc.
Cardiovascular
146d
Cleared
Nov 17, 2017
Duravess bovine pericardial vascular patch
Edwards Lifesciences, LLC
Cardiovascular
73d
Cleared
Apr 28, 2017
CardioCel 3D
Admedus Regen Pty, Ltd.
Cardiovascular
28d
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 remained relatively stable over the observed period, with 0 submissions in the last 24 months.