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Biostable Science & Engineering, Inc.

FDA 510(k) & PMA Approved Devices — 2 products

Total Devices2
Categories1
Latest Approval2017-08-10
TypeNumberDevice NameCodeDate
510(k) 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 View
510(k) 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 View