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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 K210012
Device Name Tamarin Blue PTCA RX Dilatation Catheter
Applicant
Natec Medical , Ltd.
Maeva Centra Bldg., Silicon Ave., Ebene Business Park
Reduit,  MU 72201
Applicant Contact Roy Devassy Pallippatt
Correspondent
CardioMed Device Consultants, LLC
1783 Forest Dr.
Suite 254
Annapolis,  MD  21401
Correspondent Contact Candace Cederman
Regulation Number870.5100
Classification Product Code
LOX  
Date Received01/04/2021
Decision Date 07/09/2021
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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