FDA 510(k) Application Details - K182064

Device Classification Name	Dilator, Vessel, For Percutaneous Catheterization   More FDA Info for this Device
510(K) Number	K182064
Device Name	Dilator, Vessel, For Percutaneous Catheterization
Applicant	Baylis Medical Company Inc. 2775 Matheson Blvd. East Mississauga L4W 4P7 CA Other 510(k) Applications for this Company
Contact	May Tsai 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	08/01/2018
Decision Date	03/21/2019
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