510(k) K171431
K171431 is an FDA 510(k) premarket notification submitted by Biostable Science & Engineering, Inc. for the device "HAART 200 Aortic Annuloplasty Device 19mm, HAART 200 Aortic Annuloplasty Device 21mm, HAART 200 Aortic Annuloplasty Device 23mm, HAART 200 Aortic Annuloplasty Device 25mm". The FDA issued a decision of Substantially Equivalent on August 10, 2017. The device falls under product code PST (Aortic Annuloplasty Ring), a Class II device regulated under 21 CFR 870.3800. Biostable Science & Engineering, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 10, 2017
- Date Received
- May 15, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Aortic Annuloplasty Ring
- Device Class
- Class II
- Regulation Number
- 870.3800
- Review Panel
- CV
- Submission Type
To correct annular dilatation and/or maintain annular geometry of the aortic valve.