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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous
510(k) Number K121219
Device Name ATTAIN CLARITY 6225 VENOGRAM BALLOON CATHETER
Applicant
MEDTRONIC INC.
8200 CORAL SEA STREET
MS MVSII
MOUNDS VIEW,  MN  55112
Applicant Contact WENDY SAUNDERS
Correspondent
MEDTRONIC INC.
8200 CORAL SEA STREET
MS MVSII
MOUNDS VIEW,  MN  55112
Correspondent Contact WENDY SAUNDERS
Regulation Number870.1250
Classification Product Code
DQY  
Date Received04/23/2012
Decision Date 09/25/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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