FDA 510(k) Application Details - K232562

Device Classification Name	More FDA Info for this Device
510(K) Number	K232562
Device Name	PowerWire Radiofrequency Guidewire Kit
Applicant	Baylis Medical Technologies Inc. 2645 Matheson Blvd. East Mississauga L4W5S4 CA Other 510(k) Applications for this Company
Contact	Stephanie Gallone Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PDU Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/24/2023
Decision Date	02/28/2024
Decision	SESK - SUBST EQUIV - KIT
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review