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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 K964518
FOIA Releasable 510(k) K964518
Device Name FAST-CATH TRANSSEPTAL CATHETER INTRODUCER
Applicant
DAIG CORP.
14901 DEVEAU PLACE
MINNETONKA,  MN  55345 -2126
Applicant Contact JOHN C HEINMILLER
Correspondent
DAIG CORP.
14901 DEVEAU PLACE
MINNETONKA,  MN  55345 -2126
Correspondent Contact JOHN C HEINMILLER
Regulation Number870.1340
Classification Product Code
DYB  
Date Received10/25/1996
Decision Date 05/14/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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