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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Steerable
510(k) Number K012143
Device Name 24 FR. LEFT HEART VENT CATHETER WITH PRESSURE MONITORING LINE, MODEL 12524
Applicant
Medtronic Cardiac Surgical Products
620 Watson SW
Grand Rapids,  MI  49504 -6393
Applicant Contact MELISSA HARRIGER
Correspondent
Medtronic Cardiac Surgical Products
620 Watson SW
Grand Rapids,  MI  49504 -6393
Correspondent Contact MELISSA HARRIGER
Regulation Number870.1280
Classification Product Code
DRA  
Date Received07/10/2001
Decision Date 10/24/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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