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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous
510(k) Number K020028
Device Name 6F MACH1/34356-XXX; 5F MACH1/35845-XXX; 7F MACH1/34357-XXX; 8F MACH1/34358-XXX
Applicant
BOSTON SCIENTIFIC
ONE SCIMED PLACE
MAPLE GROVE,  MN  55311
Applicant Contact TODD KORNMANN
Correspondent
BOSTON SCIENTIFIC
ONE SCIMED PLACE
MAPLE GROVE,  MN  55311
Correspondent Contact TODD KORNMANN
Regulation Number870.1250
Classification Product Code
DQY  
Date Received01/04/2002
Decision Date 01/22/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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