510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K163608Substantially Equivalent

HAART 300 Aortic Annuloplasty Device 19mm, HAART 300 Aortic Annuloplasty Device 21mm, HAART 300 Aortic Annuloplasty Device 23mm, HAART 300 Aortic Annuloplasty Device 25mm

Biostable Science & Engineering, Inc., Austin TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K163608 is the FDA 510(k) clearance record for HAART 300 Aortic Annuloplasty Device 19mm, HAART 300 Aortic Annuloplasty Device 21mm, HAART 300 Aortic Annuloplasty Device 23mm, HAART 300 Aortic Annuloplasty Device 25mm, a class II device, cleared for Biostable Science & Engineering, Inc. on under FDA product code PST (Aortic Annuloplasty Ring). FDA's definition for product code PST reads: "To correct annular dilatation and/or maintain annular geometry of the aortic valve". FDA records list 2 510(k) clearances for Biostable Science & Engineering, Inc., from to . As of , FDA records show no recalls naming K163608.

Clearance record

Decision date
Received
(90 days to decision)
Product code
PST Aortic Annuloplasty Ring
Regulation
21 CFR 870.3800
Device class
Class II
Review panel
Cardiovascular
Applicant
Biostable Science & Engineering, Inc. 2621 Ridgepoint Dr., Suite 100, Austin TX
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PST

Trailing 12 months

FDA records hold no clearances under product code PST in the trailing twelve months.

FDA records show no clearances under product code PST in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PST, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260