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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name introducer, catheter
510(k) Number K102948
Model TF8-38-62-S
Device Name TORFLEX TRANSSEPTAL GUIDING SHEATH
Original Applicant
BAYLIS MEDICAL CO., INC.
2645 matheson blvd. e
mississauga, ontario,  CA l4w 5s4
Original Contact meghal khakhar
Regulation Number870.1340
Classification Product Code
DYB  
Subsequent Product Codes
DQY   DRE  
Date Received10/05/2010
Decision Date 04/01/2011
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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