FDA 510(k) Application Details - K171081

Device Classification Name	Introducer, Catheter   More FDA Info for this Device
510(K) Number	K171081
Device Name	Introducer, Catheter
Applicant	Rhythm Xience, Inc. (RXI) 10025 Valley View Road, Suite 130 Eden Prairie, MN 55344 US Other 510(k) Applications for this Company
Contact	James Hassett Other 510(k) Applications for this Contact
Regulation Number	870.1340   More FDA Info for this Regulation Number
Classification Product Code	DYB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/11/2017
Decision Date	05/09/2017
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	Y
Expedited Review