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

Aortic Annuloplasty Ring

21 CFR 870.3800 / Cardiovascular
FDA source (opens on fda.gov)

PST is the FDA product code for Aortic Annuloplasty Ring, a class II device type, regulated under 21 CFR 870.3800. FDA's definition for this code reads: "To correct annular dilatation and/or maintain annular geometry of the aortic valve". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
PST
Device name
Aortic Annuloplasty Ring
FDA definition
To correct annular dilatation and/or maintain annular geometry of the aortic valve.
Regulation
21 CFR 870.3800
Device class
Class II
Review panel
Cardiovascular
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
Yes
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code PST

By decision year
2 clearances under product code PST with a decision year between 2017 and 2017, 2017 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code PST by decision year
YearClearances
20172

Applicants with the most clearances

Product code PST
Applicants holding the most 510(k) clearances under product code PST
ApplicantClearances
Biostable Science & Engineering, Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code