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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 K834223
Device Name CARDIOVASCULAR SPRING GUIDE WIRE
Applicant
Mallinckrodt Critical Care
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Mallinckrodt Critical Care
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number870.1330
Classification Product Code
DQX  
Date Received12/06/1983
Decision Date 02/13/1984
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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