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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 K050073
Device Name MODIFICATION TO AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER
Applicant
INVATEC INNOVATIVE TECHNOLOGIES, S.R.L.
4600 Nathan Lane North
Plymouth,  MN  55442
Applicant Contact MIKE WINEGAR
Correspondent
INVATEC INNOVATIVE TECHNOLOGIES, S.R.L.
4600 Nathan Lane North
Plymouth,  MN  55442
Correspondent Contact MIKE WINEGAR
Regulation Number870.1250
Classification Product Code
DQY  
Date Received01/12/2005
Decision Date 02/11/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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