FDA 510(k) Application Details - K191419

Device Classification Name	Catheter, Peripheral, Atherectomy   More FDA Info for this Device
510(K) Number	K191419
Device Name	Catheter, Peripheral, Atherectomy
Applicant	Rex Medical, L.P. 555 East North Lane, Suite 5035 Conshohocken, PA 19428 US Other 510(k) Applications for this Company
Contact	Colin Valentis Other 510(k) Applications for this Contact
Regulation Number	870.4875   More FDA Info for this Regulation Number
Classification Product Code	MCW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/28/2019
Decision Date	09/12/2019
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