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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 K163231
Device Name Chameleon PTA Balloon Catheter
Applicant
AV Medical Technologies Ltd
21b Habarzel Street
Tel-Aviv,  IL 6971029
Applicant Contact Limor Sandach
Correspondent
Dohmen Life Sciences Services, LLC
11925 W I-70 Frontage Road North, Suite 900
Wheat Ridge,  CO  80033
Correspondent Contact Eliza Malo
Regulation Number870.1250
Classification Product Code
LIT  
Date Received11/17/2016
Decision Date 01/17/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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