HAART - HAART 301 Instrument Set (handles and sizers)
2023-07-17
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3019892983 | 3019892983 | Corcym Inc. | 1 | Y | 2026-01-01 | 9800 Mount Pyramid Court, Suite #400 Englewood CO US 80112 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 10857160006239 | HAART - Aortic Annuloplasty Ring | 512-970-9112 | julie.thomas@biostable-s-e.com |
| 10857160006246 | HAART - Aortic Annuloplasty Device | 5129709112 | julie.thomas@biostable-s-e.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 295174 | 1744467071 | K171431 | HAART 200 Aortic Annuloplasty Device 19mm, HAART 200 Aortic Annuloplasty Device 21mm, HAART 200 Aortic Annuloplasty Device 23mm, HAART 200 Aortic Annuloplasty Device 25mm | PST | 2017-08-10 |
| 295174 | 2014115385 | 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 | PST | 2017-03-21 |
| Product code | Registration listing records | Latest decision |
|---|---|---|
| PST | 2 | 2017-08-10 |
2023-07-17
2017-09-27
2017-09-27
2017-09-27
2017-09-27
2017-05-15
2017-05-15
2017-05-15
2017-05-15
2019-10-31