FDA 510(k) Application Details - K190478

Device Classification Name	More FDA Info for this Device
510(K) Number	K190478
Device Name	Reprocessed ViewFlexÖ Xtra ICE Catheter
Applicant	Sterilmed, Inc. 5010 Cheshire Pkwy N, Suite 2 Plymouth, MN 55446 US Other 510(k) Applications for this Company
Contact	Jan Flegeau Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OWQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/27/2019
Decision Date	11/14/2019
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