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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 K010874
Device Name 6F MACH 1, MODEL 34356-XXX
Applicant
BOSTON SCIENTIFIC CORP.
ONE SCIMED PLACE
MAPLE GROVE,  MN  55311 -1566
Applicant Contact TODD KORNMANN
Correspondent
BOSTON SCIENTIFIC CORP.
ONE SCIMED PLACE
MAPLE GROVE,  MN  55311 -1566
Correspondent Contact TODD KORNMANN
Regulation Number870.1250
Classification Product Code
DQY  
Date Received03/23/2001
Decision Date 06/21/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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