FDA 510(k) Application Details - K191362

Device Classification Name	Set, Administration, Intravascular   More FDA Info for this Device
510(K) Number	K191362
Device Name	Set, Administration, Intravascular
Applicant	410 Medical, Inc. 201 West Main Street, Suite 207 Durham, NC 27701 US Other 510(k) Applications for this Company
Contact	Galen Robertson Other 510(k) Applications for this Contact
Regulation Number	880.5440   More FDA Info for this Regulation Number
Classification Product Code	FPA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/22/2019
Decision Date	05/20/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review