FDA 510(k) Application Details - K213582

Device Classification Name	Introducer, Catheter   More FDA Info for this Device
510(K) Number	K213582
Device Name	Introducer, Catheter
Applicant	Baylis Medical Company Inc. 5825 Explorer Dr. Mississauga L4W 5P6 CA Other 510(k) Applications for this Company
Contact	May Tsai Other 510(k) Applications for this Contact
Regulation Number	870.1340   More FDA Info for this Regulation Number
Classification Product Code	DYB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/12/2021
Decision Date	06/30/2022
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