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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter For Crossing Total Occlusions
510(k) Number K232562
Device Name PowerWire Radiofrequency Guidewire Kit
Applicant
Baylis Medical Technologies, Inc.
2645 Matheson Blvd. E.
Mississauga,  CA L4W5S4
Applicant Contact Stephanie Gallone
Correspondent
Baylis Medical Technologies, Inc.
2645 Matheson Blvd. E.
Mississauga,  CA L4W5S4
Correspondent Contact Stephanie Gallone
Regulation Number870.1250
Classification Product Code
PDU  
Subsequent Product Codes
DSA   MCW  
Date Received08/24/2023
Decision Date 02/28/2024
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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