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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wire, Guide, Catheter
510(k) Number K944677
Device Name SCIMED TRANSENT EX STEERABLE GUIDE WIRE AND ACCESSORIES
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 Number870.1330
Classification Product Code
DQX  
Date Received09/22/1994
Decision Date 02/08/1995
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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