510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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PSQClass II

Intracardiac Patch Or Pledget, Biologically Derived

21 CFR 870.3470 / Cardiovascular
FDA source (opens on fda.gov)

PSQ is the FDA product code for Intracardiac Patch Or Pledget, Biologically Derived, a class II device type, regulated under 21 CFR 870.3470. FDA's definition for this code reads: "To repair defects, to be used for patch grafting, to repair tissue, and to buttress sutures in the heart and vasculature". As of , FDA records hold 11 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
PSQ
Device name
Intracardiac Patch Or Pledget, Biologically Derived
FDA definition
To repair defects, to be used for patch grafting, to repair tissue, and to buttress sutures in the heart and vasculature.
Regulation
21 CFR 870.3470
Device class
Class II
Review panel
Cardiovascular
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
11
Ingested recalls
2

Clearances, product code PSQ

By decision year
11 clearances under product code PSQ with a decision year between 2017 and 2022, 2017 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code PSQ by decision year
YearClearances
20173
20181
20192
20202
20211
20222

Applicants with the most clearances

Product code PSQ
Applicants holding the most 510(k) clearances under product code PSQ
ApplicantClearances
Admedus Regen Pty, Ltd.2
Artivion, Inc.2
Synovis Life Technologies, Inc.2
ACell, Inc1
Cormatrix Cardiovascular, Inc.1
Edwards Lifesciences LLC1
Helios Cardio Inc.1
LeMaitre Vascular Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 19 companies shown, in name order