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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 K980977
Device Name PIOLAX HYDROPHILIC GUIDEWIRE
Applicant
Piolax Medical Devices, Inc.
1800 M St. NW
Washington,  DC  20036
Applicant Contact ELIZABETH BIERMAN
Correspondent
Piolax Medical Devices, Inc.
1800 M St. NW
Washington,  DC  20036
Correspondent Contact ELIZABETH BIERMAN
Regulation Number870.1330
Classification Product Code
DQX  
Date Received03/16/1998
Decision Date 10/27/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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