HAART 200 Aortic Annuloplasty Device 19mm, HAART 200 Aortic Annuloplasty Device 21mm, HAART 200 Aortic Annuloplasty Device 23mm, HAART 200 Aortic Annuloplasty Device 25mm— 510(k) K171431

Name: FDA 510(k) clearance K171431
Creator: U.S. Food and Drug Administration
Published: 2017-08-10

Substantially Equivalent

Biostable Science & Engineering, Inc.

FDA 510(k) clearance K171431 for HAART 200 Aortic Annuloplasty Device 19mm, HAART 200 Aortic Annuloplasty Device 21mm, HAART 200 Aortic Annuloplasty Device 23mm, HAART 200 Aortic Annuloplasty Device 25mm, Substantially Equivalent on 2017-08-10. Applicant: Biostable Science & Engineering, Inc.. Device class: 2.

Clearance details

Applicant: Biostable Science & Engineering, Inc.
Product code: Code PST
Device class: Class 2
Regulation: 21 CFR 870.3800
Advisory panel: Cardiovascular
Date received: 2017-05-15
Decision date: 2017-08-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

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