FDA 510(k) Application Details - K211110

Device Classification Name	Catheter, Continuous Flush   More FDA Info for this Device
510(K) Number	K211110
Device Name	Catheter, Continuous Flush
Applicant	Agile Devices, Inc. 69 Fox Hill Road Wellesley, MA 02481 US Other 510(k) Applications for this Company
Contact	Stephen Tully 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	04/14/2021
Decision Date	01/07/2022
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