FDA 510(k) Application Details - K171431

Device Classification Name	More FDA Info for this Device
510(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. 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	05/15/2017
Decision Date	08/10/2017
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