Product code PST— Cardiovascular
HAART 200 Aortic Annuloplasty Device 19mm, HAART 200 Aortic Annuloplasty Device 21mm, HAART 200 Aortic Annuloplasty Device 23mm, HAART 200 Aortic Annuloplasty Device 25mm
- Classification name
- Aortic Annuloplasty Ring
- Device class
- Class 2
- Regulation
- 21 CFR 870.3800
- Advisory panel
- Cardiovascular
- Total cleared
- 2
- First cleared
- Most recent
FDA classification definition
“To correct annular dilatation and/or maintain annular geometry of the aortic valve.”
Market context for product code PST
FDA has cleared devices under product code PST, all in 2017, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Top applicants under product code PST
Recent clearances under product code PST
- 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
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.