FDA 510(k) Application Details - K182914

Device Classification Name	Dilator, Vessel, For Percutaneous Catheterization   More FDA Info for this Device
510(K) Number	K182914
Device Name	Dilator, Vessel, For Percutaneous Catheterization
Applicant	MC3 Incorporated 2555 Bishop Circle West Dexter, MI 48130 US Other 510(k) Applications for this Company
Contact	Adam Viitala Other 510(k) Applications for this Contact
Regulation Number	870.1310   More FDA Info for this Regulation Number
Classification Product Code	DRE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/18/2018
Decision Date	10/29/2018
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