Product Code: PSQ FDA class 2 21 CFR 870.3470

Intracardiac Patch Or Pledget, Biologically Derived

Cardiovascular

The Intracardiac Patch or Pledget, Biologically Derived is an implantable cardiovascular device made from biological material, used to repair cardiac defects, perform patch grafting, repair tissue, and buttress sutures in the heart and vasculature. It is classified as FDA Class 2 under 21 CFR 870.3470 in the Cardiovascular specialty, requiring 510(k) premarket notification. Product code PSQ; flagged as an implant; not life-sustaining.

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510(k)s

FEI Numbers

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Basic Information

Product Code: PSQ
Device Class: FDA class 2
Regulation Number: 870.3470
Medical Specialty: Cardiovascular
Review Panel: CV
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✓

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

Definition

To repair defects, to be used for patch grafting, to repair tissue, and to buttress sutures in the heart and vasculature.

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 11 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K221032	Vascu-Guard Vascular Repair Patch	Oct 19, 2022	Substantially Equivalent	Synovis Life Technologies, Inc.
K221029	PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair Patch	Oct 19, 2022	Substantially Equivalent	Synovis Life Technologies, Inc.
K210331	CardiaMend Pericardial and Epicardial Reconstruction Matrix	Dec 21, 2021	Substantially Equivalent	Helios Cardio, Inc.
K200566	ADAPT Tissue	Apr 03, 2020	Substantially Equivalent	Admedus Regen Pty, Ltd.
K190882	XenoSure Biologic Patch	Feb 13, 2020	Substantially Equivalent	Lemaitre Vascular
K191734	MatriStem UBM Pericardial Patch	Nov 22, 2019	Substantially Equivalent	Acell, Inc.
K183635	PhotoFix Decellularized Bovine Pericardium	Feb 14, 2019	Substantially Equivalent	Cryolife, Inc.
K181038	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)	Oct 10, 2018	Substantially Equivalent	Cormatrix Cardiovascular, Inc.
K172085	PhotoFix Decellularized Bovine Pericardium	Dec 04, 2017	Substantially Equivalent	Cryolife, Inc.
K172660	Duravess bovine pericardial vascular patch	Nov 17, 2017	Substantially Equivalent	Edwards Lifesciences, LLC
K170951	CardioCel 3D	Apr 28, 2017	Substantially Equivalent	Admedus Regen Pty, Ltd.