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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 K101615
Device Name POWERWIRE RADIOFREQUENCY GUIDEWIRE
Applicant
Baylis Medical Co., Inc.
2645 Matheson Blvd. E.
Mississauga, Ontario,  CA L4W 5S4
Applicant Contact MEGHAL KHAKHAR
Correspondent
Baylis Medical Co., Inc.
2645 Matheson Blvd. E.
Mississauga, Ontario,  CA L4W 5S4
Correspondent Contact MEGHAL KHAKHAR
Regulation Number870.1250
Classification Product Code
PDU  
Date Received06/09/2010
Decision Date 07/28/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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