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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wire, Guide, Catheter
510(k) Number K221351
Device Name Mechanical Guidewire
Applicant
Baylis Medical Company, Inc.
5825 Explorer Dr.
Mississauga,  CA L4W5P6
Applicant Contact May Tsai
Correspondent
Baylis Medical Company, Inc.
5825 Explorer Dr.
Mississauga,  CA L4W5P6
Correspondent Contact May Tsai
Regulation Number870.1330
Classification Product Code
DQX  
Date Received05/10/2022
Decision Date 12/19/2022
Decision Substantially Equivalent (SESE)
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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