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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Septostomy
510(k) Number K150709
Device Name ProTrack RF Anchor Wire
Applicant
Baylis Medical Company, Inc.
2645 Matheson Blvd. E.
Mississauga,  CA L4W 5S4
Applicant Contact Meghal Khakhar
Correspondent
Baylis Medical Company, Inc.
2645 Matheson Blvd. E.
Mississauga,  CA L4W 5S4
Correspondent Contact Meghal Khakhar
Regulation Number870.5175
Classification Product Code
DXF  
Date Received03/19/2015
Decision Date 06/17/2015
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
Recalls CDRH Recalls
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