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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.
21 B Habarzel St.
Tel-Aviv,  IL 6971029
Applicant Contact Limor Sandach
Correspondent
Dohmen Life Sciences Services, LLC
11925 W I-70 Frontage Rd. N.
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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