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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 K946272
Device Name SCIMED(R) COURIER GUIDE CATHETER
Applicant
Scimed Peripheral Interventions
One Scimed Pl.
Maple Grove,  MN  55311
Applicant Contact DARLENE A THOMETZ
Correspondent
Scimed Peripheral Interventions
One Scimed Pl.
Maple Grove,  MN  55311
Correspondent Contact DARLENE A THOMETZ
Regulation Number870.1250
Classification Product Code
DQY  
Date Received12/23/1994
Decision Date 04/17/1995
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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