Aortic Annuloplasty Ring
The Aortic Annuloplasty Ring is an implantable cardiovascular device used to correct annular dilatation and/or maintain annular geometry of the aortic valve, typically implanted during aortic valve repair surgery to restore or preserve normal valve function. It is classified as FDA Class 2 under 21 CFR 870.3800 in the Cardiovascular specialty, requiring 510(k) premarket notification. Product code PST; flagged as both an implant and life-sustaining, reflecting its critical role in cardiac function.
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Basic Information
- Product Code
- PST
- Device Class
- FDA class 2
- Regulation Number
- 870.3800
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 1
Device Characteristics
Definition
To correct annular dilatation and/or maintain annular geometry of the aortic valve.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| 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 | Aug 10, 2017 | Substantially Equivalent | Biostable Science & Engineering, Inc. |
| 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 | Mar 21, 2017 | Substantially Equivalent | Biostable Science & Engineering, Inc. |
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.