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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name introducer, catheter
510(k) Number K982187
Device Name FAST-CATH INTRA-CARDIAC INTRODUCER
Original Applicant
DAIG CORP.
14901 deveau place
minnetonka,  MN  55345 -2126
Original Contact dean bruhn-ding
Regulation Number870.1340
Classification Product Code
DYB  
Date Received06/22/1998
Decision Date 09/16/1998
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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