# K163608: HAART 300 Aortic Annuloplasty Device 19mm, HAART 300 Aortic Annuloplasty Device 21mm, HAART 300 Aortic Annuloplasty Device 23mm, HAART 300 Aortic Annuloplasty Device 25mm

- Pathway: 510(k) (Traditional)
- Applicant: Biostable Science & Engineering, Inc.
- Decided: Mar 21, 2017 after 90 days
- Product code: PST (Aortic Annuloplasty Ring)
- Device class: 2
- Regulation: 21 CFR 870.3800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K923367 (1993). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103520: Carpentier-Edwards Physio Tricuspid Annuloplasty Ring, Edwards Lifesciences, LLC (2011) Summary page 4.

## Most influential descendants
- K171431: HAART 200 Aortic Annuloplasty Device 19mm, HAART 200 Aortic Annuloplasty Device 21mm, HAART 200 Aortic Annuloplasty Device 23mm, HAART 200 Aortic Annuloplasty Device 25mm (2017), 0 descendants of its own

## Indications for use
The HAART 300 Aortic Annuloplasty Device is intended to be used to correct annular dilatation and/or maintain annular geometry of the aortic valve in patients with tri-leaflet valve morphology with moderate to severe aortic insufficiency who are undergoing aortic valve repair due to symptoms or as part of a repair for an aortic root aneurysm.

Source page: https://510kreport.com/device/K163608
Methodology: https://510kreport.com/methodology