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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 K952345
Device Name MEDI-TECH PLATFORM GUIDE CATHETER
Applicant
Medi-Tech, Inc.
One Scimed Pl.
Maple Grove,  MN  55311
Applicant Contact DARLENE A THOMETZ
Correspondent
Medi-Tech, Inc.
One Scimed Pl.
Maple Grove,  MN  55311
Correspondent Contact DARLENE A THOMETZ
Regulation Number870.1250
Classification Product Code
DQY  
Date Received05/19/1995
Decision Date 08/17/1995
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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