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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 K050276
Device Name DIVER C.E. CATHETER
Applicant
Invatec Innovative Technologies, S.R.L.
4600 Nathan Lane N
Plymouth,  MN  55442
Applicant Contact PATRICE STROMBERG
Correspondent
Invatec Innovative Technologies, S.R.L.
4600 Nathan Lane N
Plymouth,  MN  55442
Correspondent Contact PATRICE STROMBERG
Regulation Number870.5150
Classification Product Code
QEZ  
Date Received02/07/2005
Decision Date 03/07/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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