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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 K970401
Device Name MEDI-DYNE GUIDING CATHETER
Applicant
Medi-Dyne, Inc.
604 Queensbury Ave.
Queensbury,  NY  12804
Applicant Contact NORMA HALL
Correspondent
Medi-Dyne, Inc.
604 Queensbury Ave.
Queensbury,  NY  12804
Correspondent Contact NORMA HALL
Regulation Number870.1250
Classification Product Code
DQY  
Date Received02/03/1997
Decision Date 08/01/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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