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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 K853999
Device Name GUIDE WIRE
Applicant
Target Therapeutics
2100 S. Sepulveda Blvd.
Los Angeles,  CA  90025
Applicant Contact MARIE DANIELS
Correspondent
Target Therapeutics
2100 S. Sepulveda Blvd.
Los Angeles,  CA  90025
Correspondent Contact MARIE DANIELS
Regulation Number870.1330
Classification Product Code
DQX  
Date Received09/30/1985
Decision Date 11/05/1985
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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