The following data is part of a premarket notification filed by Biostable Science & Engineering Inc. with the FDA 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.
| Device ID | K163608 |
| 510k Number | K163608 |
| 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 |
| Classification | Aortic Annuloplasty Ring |
| Applicant | BioStable Science & Engineering Inc. 2621 Ridgepoint Dr., Suite 100 Austin, TX 78754 |
| Contact | Julie Thomas |
| Correspondent | Janice M. Hogan HOGAN LOVELLS US LLP 1835 MARKET ST 29TH FLOOR Philadelphia, PA 19103 |
| Product Code | PST |
| CFR Regulation Number | 870.3800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-21 |
| Decision Date | 2017-03-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10857160006307 | K163608 | 000 |
| 10857160006291 | K163608 | 000 |
| 10857160006284 | K163608 | 000 |
| 10857160006277 | K163608 | 000 |
| 10857160006314 | K163608 | 000 |