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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, Diagnostic
510(k) Number K052637
Device Name THEROX INFUSION CATHETER, MODEL INCA-1
Applicant
Therox, Inc.
2400 Michelson Dr.
Irvine,  CA  92612
Applicant Contact DAVID W MULLIS JR.
Correspondent
Underwriters Laboratories, Inc.
1285 Walt Whitman Rd.
Melville,  NY  11747
Regulation Number870.1200
Classification Product Code
DQO  
Date Received09/26/2005
Decision Date 03/08/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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