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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 K973465
Device Name LATIS GRAFT CLEANING CATHETER
Applicant
Applied Medical Resources
26051 Merit Cir.
Bldg. 104
Launa Hills,  CA  92653
Applicant Contact MARY JO STEGWELL
Correspondent
Applied Medical Resources
26051 Merit Cir.
Bldg. 104
Launa Hills,  CA  92653
Correspondent Contact MARY JO STEGWELL
Regulation Number870.5150
Classification Product Code
DXE  
Date Received09/12/1997
Decision Date 02/19/1998
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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