FDA 510(k) Application Details - K190318

Device Classification Name	Clamp, Vascular   More FDA Info for this Device
510(K) Number	K190318
Device Name	Clamp, Vascular
Applicant	VASOInnovations Inc. 1260 Huntington Drive, Suite 208 South Pasadena, CA 91030 US Other 510(k) Applications for this Company
Contact	Raj Sardesai Other 510(k) Applications for this Contact
Regulation Number	870.4450   More FDA Info for this Regulation Number
Classification Product Code	DXC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/13/2019
Decision Date	03/14/2019
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	Y
Expedited Review