FDA 510(k) Application Details - K181132

Device Classification Name	Ring, Annuloplasty   More FDA Info for this Device
510(K) Number	K181132
Device Name	Ring, Annuloplasty
Applicant	Medtronic 1851 East Deere Ave Santa Ana, CA 92705 US Other 510(k) Applications for this Company
Contact	Tracy Gray Other 510(k) Applications for this Contact
Regulation Number	870.3800   More FDA Info for this Regulation Number
Classification Product Code	KRH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/30/2018
Decision Date	05/29/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review