FDA 510(k) Application Details - K192422

Device Classification Name	Catheter, Steerable   More FDA Info for this Device
510(K) Number	K192422
Device Name	Catheter, Steerable
Applicant	Freudenberg Medical LLC 2301 Centennial Boulevard Jeffersonville, IN 47130 US Other 510(k) Applications for this Company
Contact	Mary Prunty Other 510(k) Applications for this Contact
Regulation Number	870.1280   More FDA Info for this Regulation Number
Classification Product Code	DRA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/04/2019
Decision Date	10/04/2019
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