FDA 510(k) Application Details - K233647

Device Classification Name	Dilator, Vessel, For Percutaneous Catheterization   More FDA Info for this Device
510(K) Number	K233647
Device Name	Dilator, Vessel, For Percutaneous Catheterization
Applicant	Baylis Medical Company Inc. 5825 Explorer Drive Mississauga L4W5P6 CA Other 510(k) Applications for this Company
Contact	Christina Dowd 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	11/14/2023
Decision Date	12/14/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review