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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous
510(k) Number K132701
Device Name PRIMI SUPPORT CATHETER
Applicant
Thermopeutix, Inc.
9951b Businesspark Ave.
San Diego,  CA  92131
Applicant Contact JASON FORD
Correspondent
Thermopeutix, Inc.
9951b Businesspark Ave.
San Diego,  CA  92131
Correspondent Contact JASON FORD
Regulation Number870.1250
Classification Product Code
DQY  
Date Received08/29/2013
Decision Date 09/26/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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