FDA 510(k) Application Details - K221351

Device Classification Name	Wire, Guide, Catheter   More FDA Info for this Device
510(K) Number	K221351
Device Name	Wire, Guide, 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	870.1330   More FDA Info for this Regulation Number
Classification Product Code	DQX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/10/2022
Decision Date	12/19/2022
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