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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Angioplasty, Peripheral, Transluminal
510(k) Number K152230
Device Name Ebony PTA .014 RX Pheripheral Dilatation Catheter
Applicant
Natec Medical
Maeva Centre Bldg., Silicon Ave., Ebene Business Park
Reduit,  MU 72201
Applicant Contact XAVIER DE BUCHERE
Correspondent
CardioMed Device Consultants, LLC
5523 Research Park Dr., Suite 205
Baltimore,  MD  21228
Correspondent Contact JUDITH DANIELSON
Regulation Number870.1250
Classification Product Code
LIT  
Date Received08/07/2015
Decision Date 09/03/2015
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
Recalls CDRH Recalls
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