FDA 510(k) Application Details - K191731

Device Classification Name	Catheter, Continuous Flush   More FDA Info for this Device
510(K) Number	K191731
Device Name	Catheter, Continuous Flush
Applicant	Instylla, Inc. 204 Second Avenue Waltham, MA 02451 US Other 510(k) Applications for this Company
Contact	Amita Shah Other 510(k) Applications for this Contact
Regulation Number	870.1210   More FDA Info for this Regulation Number
Classification Product Code	KRA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/28/2019
Decision Date	08/13/2019
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