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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 K871850
Device Name TELEFLEX STEERABLE GUIDEWIRE
Applicant
Teleflexmedical, Inc.
Tall Pines Park
Jeffrey,  NH  03452
Applicant Contact RICHARD GARDNER
Correspondent
Teleflexmedical, Inc.
Tall Pines Park
Jeffrey,  NH  03452
Correspondent Contact RICHARD GARDNER
Regulation Number870.1330
Classification Product Code
DQX  
Date Received05/12/1987
Decision Date 01/27/1988
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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