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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name aspiration thrombectomy catheter
510(k) Number K051917
Device Name DIVER C.E. CATHETER
Applicant
INVATEC INNOVATIVE TECHNOLOGIES, S.R.L.
4600 Nathan Lane North
Plymouth,  MN  55442
Applicant Contact STEPHANIE K ISGRIGG ROBINSON
Correspondent
INVATEC INNOVATIVE TECHNOLOGIES, S.R.L.
4600 Nathan Lane North
Plymouth,  MN  55442
Correspondent Contact STEPHANIE K ISGRIGG ROBINSON
Regulation Number870.5150
Classification Product Code
QEZ  
Date Received07/15/2005
Decision Date 08/08/2005
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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