FDA 510(k) Application Details - DEN190043

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN190043
Device Name	SafeBreak Vascular
Applicant	Site Saver, Inc. d/b/a Lineus Medical 179 N. Church Ave, Suite 202 Fayetteville, AR 72701 US Other 510(k) Applications for this Company
Contact	Lemuel V. Clement Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QOI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/18/2019
Decision Date	05/27/2021
Decision	DENG -
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review