510(k) K171431
- 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
- Applicant
- BioStable Science & Engineering, Inc.
- 510(k) number
- K171431
- Product code
- PST
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-08-10
- Date received
- 2017-05-15
- Regulation
- 870.3800
- Classification name
- Aortic Annuloplasty Ring
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Julie Thomas
- Address
- 2621 Ridgepoint Dr., Suite 100 Austin TX US 78754 78754
FDA Registration Numbers#
- 3005687633
- 3019892983
- 3003477135
- 1424263
Source Documents#
Other 510(k) Records For Product Code PST #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 | Biostable Science & Engineering, Inc. | 2017-03-21 |
Legacy Summary#
summary
FDA Review#
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