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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dilator, Vessel, For Percutaneous Catheterization
510(k) Number K842113
Device Name AMENDMENT TO ANGIOGRAPHY KIT W/ADDIT
Applicant
Mallinckrodt Critical Care
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Mallinckrodt Critical Care
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number870.1310
Classification Product Code
DRE  
Date Received03/19/1984
Decision Date 07/13/1984
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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