HAART 300 Aortic Annuloplasty Device 19mm, HAART 300 Aortic Annuloplasty Device 21mm, HAART 300 Aortic Annuloplasty Device 23mm, HAART 300 Aortic Annuloplasty Device 25mm
FDA 510(k) K163608 · Biostable Science & Engineering, Inc.
510(k) numberK163608
Submission
- Device name
- HAART 300 Aortic Annuloplasty Device 19mm, HAART 300 Aortic Annuloplasty Device 21mm, HAART 300 Aortic Annuloplasty Device 23mm, HAART 300 Aortic Annuloplasty Device 25mm
- Applicant
- Biostable Science & Engineering, Inc.
Austin, TX, US - Received
- December 21, 2016
- Decision date
- March 21, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PST – Aortic Annuloplasty Ring
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.3800
- Specialty
- Cardiovascular
- Implant
- Yes
- Life-sustaining
- Yes
To correct annular dilatation and/or maintain annular geometry of the aortic valve.
Other 510(k)s with product code PST
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K171431 | HAART 200 Aortic Annuloplasty Device 19mm, HAART 200 Aortic Annuloplasty Device 21mm…PST · Traditional | Biostable Science & Engineering, Inc. | 08/10/2017SE |
More from Biostable Science & Engineering, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K171431 | HAART 200 Aortic Annuloplasty Device 19mm, HAART 200 Aortic Annuloplasty Device 21mm…PST · Traditional | 08/10/2017SE |
Questions and answers
When was HAART 300 Aortic Annuloplasty Device 19mm, HAART 300 Aortic Annuloplasty Device 21mm, HAART 300 Aortic Annuloplasty Device 23mm, HAART 300 Aortic Annuloplasty Device 25mm cleared by the FDA?
HAART 300 Aortic Annuloplasty Device 19mm, HAART 300 Aortic Annuloplasty Device 21mm, HAART 300 Aortic Annuloplasty Device 23mm, HAART 300 Aortic Annuloplasty Device 25mm (K163608) received a 510(k) decision of Substantially Equivalent on March 21, 2017, 90 days after the submission was received.
What is the product code of K163608?
The FDA product code is PST – Aortic Annuloplasty Ring, a Class II (moderate risk) device regulated under 21 CFR 870.3800.