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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 K931584
Device Name SCIMED TRANSPORT STEERABLE GUIDE WIRE AND ACCESS.
Applicant
Scimed
2905 Northwest Blvd.
Suite 60
Plymouth,  MN  55441 -2644
Applicant Contact DARLENE A THOMETZ
Correspondent
Scimed
2905 Northwest Blvd.
Suite 60
Plymouth,  MN  55441 -2644
Correspondent Contact DARLENE A THOMETZ
Regulation Number870.1330
Classification Product Code
DQX  
Date Received03/31/1993
Decision Date 07/01/1993
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
Recalls CDRH Recalls
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