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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 K122431
Device Name HEARTSPAN STEERABLE INTRODUCER KIT
Original Applicant
THOMAS MEDICAL PRODUCTS, INC.
65 great valley pkwy.
malvern,  PA  19355
Original Contact tim stoudt
Regulation Number870.1340
Classification Product Code
DYB  
Date Received08/10/2012
Decision Date 01/29/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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