FDA 510(k) Application Details - DEN190038

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN190038
Device Name	Surfacer Inside-Out Access Catheter System
Applicant	Bluegrass Vascular Technologies, Inc. 12500 Network Boulevard, Suite 308 San Antonio, TX 78249 US Other 510(k) Applications for this Company
Contact	Gabriele G. Niederauer Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QJH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/15/2019
Decision Date	02/10/2020
Decision	DENG -
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review