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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 K062809
Device Name ADMIRAL XTREME PTA CATHETER
Applicant
Invatec Innovative Technologies
9600 54th Ave. N.
Plymouth,  MN  55442
Applicant Contact David Worrell
Correspondent
Invatec Innovative Technologies
9600 54th Ave. N.
Plymouth,  MN  55442
Correspondent Contact David Worrell
Regulation Number870.1250
Classification Product Code
DQY  
Date Received09/19/2006
Decision Date 10/18/2006
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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