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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular Occluding, Temporary
510(k) Number K112219
Device Name TAPAS CATHETER
Applicant
Thermopeutix, Inc.
9925b Business Park Ave.
San Diego,  CA  92131
Applicant Contact THOMAS SCHROEDER
Correspondent
Thermopeutix, Inc.
9925b Business Park Ave.
San Diego,  CA  92131
Correspondent Contact THOMAS SCHROEDER
Regulation Number870.4450
Classification Product Code
MJN  
Date Received08/02/2011
Decision Date 11/18/2011
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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