FDA 510(k) Application Details - K183305

Device Classification Name	Catheter, Percutaneous   More FDA Info for this Device
510(K) Number	K183305
Device Name	Catheter, Percutaneous
Applicant	Tractus Vascular LLC 15 Christopher Way Eatontown, NJ 07724 US Other 510(k) Applications for this Company
Contact	Janet Burpee Other 510(k) Applications for this Contact
Regulation Number	870.1250   More FDA Info for this Regulation Number
Classification Product Code	DQY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/28/2018
Decision Date	08/05/2019
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