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

Left Atrial Appendage Clip, Implantable

21 CFR 878.4300 / General, Plastic Surgery
FDA source (opens on fda.gov)

PZX is the FDA product code for Left Atrial Appendage Clip, Implantable, a class II device type, regulated under 21 CFR 878.4300. FDA's definition for this code reads: "Intended to occlude the left atrial appendage". As of , FDA records hold 10 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
PZX
Device name
Left Atrial Appendage Clip, Implantable
FDA definition
Intended to occlude the left atrial appendage.
Regulation
21 CFR 878.4300
Device class
Class II
Review panel
General, Plastic Surgery
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
10
Ingested recalls
0

Clearances, product code PZX

By decision year
10 clearances under product code PZX with a decision year between 2018 and 2026, 2023 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code PZX by decision year
YearClearances
20181
20191
20211
20221
20232
20241
20251
20262

Applicants with the most clearances

Product code PZX
Applicants holding the most 510(k) clearances under product code PZX
ApplicantClearances
AtriCure, Inc.6
Syntheon, LLC2
Edwards Lifesciences LLC1
Genesee BioMedical, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code