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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 K924491
Device Name INTRODUCER, PERCUTANEOUS -- MODIFICATION
Applicant
Medamicus, Inc.
15301 Hwy. 55 W.
Minneapolis,  MN  55447
Applicant Contact DAVID A LIEBL
Correspondent
Medamicus, Inc.
15301 Hwy. 55 W.
Minneapolis,  MN  55447
Correspondent Contact DAVID A LIEBL
Regulation Number870.1340
Classification Product Code
DYB  
Date Received08/20/1992
Decision Date 11/18/1992
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
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