FDA 510(k) Application Details - K182512

Device Classification Name	Catheter, Percutaneous   More FDA Info for this Device
510(K) Number	K182512
Device Name	Catheter, Percutaneous
Applicant	Route 92 Medical Inc. 1700 S. El Camino Real, Suite 206 San Mateo, CA 94402 US Other 510(k) Applications for this Company
Contact	Kathy Tansey 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	09/12/2018
Decision Date	12/10/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
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