FDA 510(k) Applications Submitted by Julie Thomas

FDA 510(k) Number Submission Date Device Name Applicant
K171431 05/15/2017 HAART 200 Aortic Annuloplasty Device 19mm, HAART 200 Aortic Annuloplasty Device 21mm, HAART 200 Aortic Annuloplasty Device 23mm, HAART 200 Aortic Annuloplasty Device 25mm BioStable Science & Engineering, Inc.
K163608 12/21/2016 HAART 300 Aortic Annuloplasty Device 19mm, HAART 300 Aortic Annuloplasty Device 21mm, HAART 300 Aortic Annuloplasty Device 23mm, HAART 300 Aortic Annuloplasty Device 25mm BioStable Science & Engineering Inc.


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