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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, embolectomy
510(k) Number K992368
Device Name LEMAITRE EMBOLECTOMY CATHETER
Applicant
VASCUTECH, INC.
164 MIDDLESEX TURNPIKE
BURLINGTON,  MA  01803
Applicant Contact TRENT G KAMKE
Correspondent
VASCUTECH, INC.
164 MIDDLESEX TURNPIKE
BURLINGTON,  MA  01803
Correspondent Contact TRENT G KAMKE
Regulation Number870.5150
Classification Product Code
DXE  
Date Received07/15/1999
Decision Date 12/09/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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