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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular Occluding, Temporary
510(k) Number K992942
Device Name LEMAITRE OCCLUSION CATHETER
Applicant
Vascutech, Inc.
164 Middlesex Tpke.
Burlington,  MA  01803
Applicant Contact TRENT G KAMKE
Correspondent
Vascutech, Inc.
164 Middlesex Tpke.
Burlington,  MA  01803
Correspondent Contact TRENT G KAMKE
Regulation Number870.4450
Classification Product Code
MJN  
Date Received08/31/1999
Decision Date 04/13/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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