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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, percutaneous
510(k) Number K083919
Device Name AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER
Applicant
INVATEC INNOVATIVE TECHNOLOGIES, S.R.L.
3101 EMRICK BLVD
SUITE 113
BETHLEHEM,  PA  18020
Applicant Contact STEVE CAMP
Correspondent
INVATEC INNOVATIVE TECHNOLOGIES, S.R.L.
3101 EMRICK BLVD
SUITE 113
BETHLEHEM,  PA  18020
Correspondent Contact STEVE CAMP
Regulation Number870.1250
Classification Product Code
DQY  
Date Received12/31/2008
Decision Date 03/13/2009
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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