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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheters, Transluminal Coronary Angioplasty, Percutaneous
510(k) Number K112735
Device Name TAMARIN BLUE PTCA RX DILATATION CATHETER
Applicant
Natec Medical , Ltd.
1468 Harwell Ave.
Crofton,  MD  21114
Applicant Contact E.J. Smith
Correspondent
Natec Medical , Ltd.
1468 Harwell Ave.
Crofton,  MD  21114
Correspondent Contact E.J. Smith
Regulation Number870.5100
Classification Product Code
LOX  
Date Received09/20/2011
Decision Date 11/02/2012
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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