HAART 300 Aortic Annuloplasty Device 19mm, HAART 300 Aortic Annuloplasty Device 21mm, HAART 300 Aortic Annuloplasty Device 23mm, HAART 300 Aortic Annuloplasty Device 25mm— 510(k) K163608
Substantially EquivalentBiostable Science & Engineering, Inc.
FDA 510(k) clearance K163608 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, Substantially Equivalent on 2017-03-21. Applicant: Biostable Science & Engineering, Inc.. Device class: 2.
Clearance details
- Applicant
- Biostable Science & Engineering, Inc.
- Product code
- Code PST
- Device class
- Class 2
- Regulation
- 21 CFR 870.3800
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Austin, TX, US
Recent devices under product code PST
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