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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wire, Guide, Catheter
510(k) Number K112674
Device Name NAVIS TORQUER
Applicant
Navis Medical,Inc
5705 Whispering Trl.
Galena,  OH  43021
Applicant Contact MATTHEW J HUDDLESTON
Correspondent
Navis Medical,Inc
5705 Whispering Trl.
Galena,  OH  43021
Correspondent Contact MATTHEW J HUDDLESTON
Regulation Number870.1330
Classification Product Code
DQX  
Date Received09/14/2011
Decision Date 07/06/2012
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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