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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 K251915
Device Name Amethyst HP PTA OTW 0.035 Catheter
Applicant
Natec Medical , Ltd.
Ava Technoparl, Medtech Rd., Cote D'Or Technopole,
Minissy, Cote D'Or
Moka,  MU 80829
Applicant Contact Pallippatt Roy Devassy
Correspondent
Natec Medical , Ltd.
Ava Technoparl, Medtech Rd., Cote D'Or Technopole,
Minissy, Cote D'Or
Moka,  MU 80829
Correspondent Contact Pallippatt Roy Devassy
Regulation Number870.1250
Classification Product Code
LIT  
Date Received06/23/2025
Decision Date 12/18/2025
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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