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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 K802473
Device Name BENZALKONIUM-HEPARIN COATED GUIDEWIRES
Applicant
Medrad, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Medrad, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number870.1330
Classification Product Code
DQX  
Date Received11/09/1980
Decision Date 11/12/1980
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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