HAART 200 Aortic Annuloplasty Device 19mm, HAART 200 Aortic Annuloplasty Device 21mm, HAART 200 Aortic Annuloplasty Device 23mm, HAART 200 Aortic Annuloplasty Device 25mm
FDA 510(k) clearance K171431 · decided 2017-08-10
Clearance details
- K-number
- K171431
- Device name
- 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.
- Decision
- Substantially Equivalent
- Date received
- 2017-05-15
- Decision date
- 2017-08-10
- Days to decision
- 87 days
- Clearance type
- Traditional
- Product code
- PST
- Device class
- 2
- Regulation number
- 870.3800
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Austin, TX, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| 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) | Biostable Science & Engineering, Inc. | 2017-03-21 |
Recalls involving this device
No recalls on record reference this clearance.