FDA 510(k) Application Details - K163608

Device Classification Name	More FDA Info for this Device
510(K) Number	K163608
Device Name	HAART 300 Aortic Annuloplasty Device 19mm, HAART 300 Aortic Annuloplasty Device 21mm, HAART 300 Aortic Annuloplasty Device 23mm, HAART 300 Aortic Annuloplasty Device 25mm
Applicant	BioStable Science & Engineering Inc. 2621 Ridgepoint Dr., Suite 100 Austin, TX 78754 US Other 510(k) Applications for this Company
Contact	Julie Thomas Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PST Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/21/2016
Decision Date	03/21/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review